From 24fbed0bf203df13efdbd747bd063650de5418da Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Thu, 9 Jul 2026 12:15:59 -0400 Subject: [PATCH 01/13] Fix env and tests for CORE-000039 --- Published/CORE-000039/negative/01/data/.env | 2 +- .../negative/01/data/_variables.csv | 1 + Published/CORE-000039/negative/01/data/sv.csv | 22 +++++++++---------- .../negative/01/results/results.csv | 14 ++++++++++-- .../negative/02/results/results.csv | 17 -------------- .../{negative => positive}/02/data/.env | 2 +- .../02/data/_datasets.csv | 0 .../02/data/_variables.csv | 1 - .../{negative => positive}/02/data/sv.csv | 22 +++++++++---------- .../{negative => positive}/02/data/tv.csv | 0 .../positive/02/results/results.csv | 1 + 11 files changed, 38 insertions(+), 44 deletions(-) delete mode 100644 Published/CORE-000039/negative/02/results/results.csv rename Published/CORE-000039/{negative => positive}/02/data/.env (55%) rename Published/CORE-000039/{negative => positive}/02/data/_datasets.csv (100%) rename Published/CORE-000039/{negative => positive}/02/data/_variables.csv (95%) rename Published/CORE-000039/{negative => positive}/02/data/sv.csv (81%) rename Published/CORE-000039/{negative => positive}/02/data/tv.csv (100%) create mode 100644 Published/CORE-000039/positive/02/results/results.csv diff --git a/Published/CORE-000039/negative/01/data/.env b/Published/CORE-000039/negative/01/data/.env index 8e0185650..8f9bf60aa 100644 --- a/Published/CORE-000039/negative/01/data/.env +++ b/Published/CORE-000039/negative/01/data/.env @@ -1,2 +1,2 @@ PRODUCT=SDTMIG -VERSION=3-3 +VERSION=3-4 diff --git a/Published/CORE-000039/negative/01/data/_variables.csv b/Published/CORE-000039/negative/01/data/_variables.csv index c4acf1613..ff348e0c0 100644 --- a/Published/CORE-000039/negative/01/data/_variables.csv +++ b/Published/CORE-000039/negative/01/data/_variables.csv @@ -10,6 +10,7 @@ sv,SVENDTC,End Date/Time of Visit,Char,10 sv,SVSTDY,Study Day of Start of Visit,Num,8 sv,SVENDY,Study Day of End of Visit,Num,8 sv,SVUPDES,Description of Unplanned Visit,Char,200 +sv,SVPRESP,Pre-specified,Char,1 tv,STUDYID,Study Identifier,Char,12 tv,DOMAIN,Domain Abbreviation,Char,2 tv,VISITNUM,Visit Number,Num,8 diff --git a/Published/CORE-000039/negative/01/data/sv.csv b/Published/CORE-000039/negative/01/data/sv.csv index ff7332b94..b7227b07b 100644 --- a/Published/CORE-000039/negative/01/data/sv.csv +++ b/Published/CORE-000039/negative/01/data/sv.csv @@ -1,11 +1,11 @@ -STUDYID,DOMAIN,USUBJID,VISITNUM,VISIT,VISITDY,SVSTDTC,SVENDTC,SVSTDY,SVENDY,SVUPDES -CDISCPILOT01,SV,CDISC001,12,SCREENING 1,-28,2012-11-23,2012-11-23,-7,-7, -CDISCPILOT01,SV,CDISC001,13,SCREENING 2,-3,2012-11-28,2012-11-28,-2,-2, -CDISCPILOT01,SV,CDISC001,14,BASELINE,1,2012-11-30,2012-11-30,1,1, -CDISCPILOT01,SV,CDISC001,15,WEEK 2,15,2012-12-13,2012-12-13,14,14, -CDISCPILOT01,SV,CDISC001,16,WEEK 4,29,2012-12-26,2012-12-26,27,27, -CDISCPILOT01,SV,CDISC001,5.01,WEEK 4: UNSCHEDULED 01,,2012-12-28,2012-12-28,29,29,UNSCHEDULED LABS -CDISCPILOT01,SV,CDISC001,17,WEEK 6,43,2013-01-10,2013-01-10,42,42, -CDISCPILOT01,SV,CDISC001,19,WEEK 8,57,2013-01-23,2013-01-23,55,55, -CDISCPILOT01,SV,CDISC001,101,EARLY DISCONTINUATION,,2013-02-14,2013-02-14,77,77, -CDISCPILOT01,SV,CDISC001,201,EARLY DISCONTINUATION RETRIEVAL,,2013-05-20,2013-05-20,172,172, +STUDYID,DOMAIN,USUBJID,VISITNUM,VISIT,VISITDY,SVSTDTC,SVENDTC,SVSTDY,SVENDY,SVUPDES,SVPRESP +CDISCPILOT01,SV,CDISC001,12,SCREENING 1,-28,2012-11-23,2012-11-23,-7,-7,, +CDISCPILOT01,SV,CDISC001,13,SCREENING 2,-3,2012-11-28,2012-11-28,-2,-2,, +CDISCPILOT01,SV,CDISC001,14,BASELINE,1,2012-11-30,2012-11-30,1,1,,Y +CDISCPILOT01,SV,CDISC001,15,WEEK 2,15,2012-12-13,2012-12-13,14,14,,Y +CDISCPILOT01,SV,CDISC001,16,WEEK 4,29,2012-12-26,2012-12-26,27,27,,Y +CDISCPILOT01,SV,CDISC001,5.01,WEEK 4: UNSCHEDULED 01,,2012-12-28,2012-12-28,29,29,UNSCHEDULED LABS,Y +CDISCPILOT01,SV,CDISC001,17,WEEK 6,43,2013-01-10,2013-01-10,42,42,,Y +CDISCPILOT01,SV,CDISC001,19,WEEK 8,57,2013-01-23,2013-01-23,55,55,,Y +CDISCPILOT01,SV,CDISC001,101,EARLY DISCONTINUATION,,2013-02-14,2013-02-14,77,77,,Y +CDISCPILOT01,SV,CDISC001,201,EARLY DISCONTINUATION RETRIEVAL,,2013-05-20,2013-05-20,172,172,,Y diff --git a/Published/CORE-000039/negative/01/results/results.csv b/Published/CORE-000039/negative/01/results/results.csv index fdef18dfd..e81dcbc18 100644 --- a/Published/CORE-000039/negative/01/results/results.csv +++ b/Published/CORE-000039/negative/01/results/results.csv @@ -1,7 +1,17 @@ Dataset,Record,Variable,Value +SV,3,SVPRESP,Y +SV,3,VISITNUM,14.0 +SV,4,SVPRESP,Y +SV,4,VISITNUM,15.0 +SV,5,SVPRESP,Y +SV,5,VISITNUM,16.0 SV,6,SVPRESP,Y SV,6,VISITNUM,5.01 +SV,7,SVPRESP,Y +SV,7,VISITNUM,17.0 +SV,8,SVPRESP,Y +SV,8,VISITNUM,19.0 SV,9,SVPRESP,Y -SV,9,VISITNUM,101 +SV,9,VISITNUM,101.0 SV,10,SVPRESP,Y -SV,10,VISITNUM,201 +SV,10,VISITNUM,201.0 diff --git a/Published/CORE-000039/negative/02/results/results.csv b/Published/CORE-000039/negative/02/results/results.csv deleted file mode 100644 index 683030425..000000000 --- a/Published/CORE-000039/negative/02/results/results.csv +++ /dev/null @@ -1,17 +0,0 @@ -Dataset,Record,Variable,Value -SV,3,SVPRESP,Y -SV,3,VISITNUM,14 -SV,4,SVPRESP,Y -SV,4,VISITNUM,15 -SV,5,SVPRESP,Y -SV,5,VISITNUM,16 -SV,6,SVPRESP,Y -SV,6,VISITNUM,5.01 -SV,7,SVPRESP,Y -SV,7,VISITNUM,17 -SV,8,SVPRESP,Y -SV,8,VISITNUM,19 -SV,9,SVPRESP,Y -SV,9,VISITNUM,101 -SV,10,SVPRESP,Y -SV,10,VISITNUM,201 diff --git a/Published/CORE-000039/negative/02/data/.env b/Published/CORE-000039/positive/02/data/.env similarity index 55% rename from Published/CORE-000039/negative/02/data/.env rename to Published/CORE-000039/positive/02/data/.env index 8e0185650..8f9bf60aa 100644 --- a/Published/CORE-000039/negative/02/data/.env +++ b/Published/CORE-000039/positive/02/data/.env @@ -1,2 +1,2 @@ PRODUCT=SDTMIG -VERSION=3-3 +VERSION=3-4 diff --git a/Published/CORE-000039/negative/02/data/_datasets.csv b/Published/CORE-000039/positive/02/data/_datasets.csv similarity index 100% rename from Published/CORE-000039/negative/02/data/_datasets.csv rename to Published/CORE-000039/positive/02/data/_datasets.csv diff --git a/Published/CORE-000039/negative/02/data/_variables.csv b/Published/CORE-000039/positive/02/data/_variables.csv similarity index 95% rename from Published/CORE-000039/negative/02/data/_variables.csv rename to Published/CORE-000039/positive/02/data/_variables.csv index ff348e0c0..c4acf1613 100644 --- a/Published/CORE-000039/negative/02/data/_variables.csv +++ b/Published/CORE-000039/positive/02/data/_variables.csv @@ -10,7 +10,6 @@ sv,SVENDTC,End Date/Time of Visit,Char,10 sv,SVSTDY,Study Day of Start of Visit,Num,8 sv,SVENDY,Study Day of End of Visit,Num,8 sv,SVUPDES,Description of Unplanned Visit,Char,200 -sv,SVPRESP,Pre-specified,Char,1 tv,STUDYID,Study Identifier,Char,12 tv,DOMAIN,Domain Abbreviation,Char,2 tv,VISITNUM,Visit Number,Num,8 diff --git a/Published/CORE-000039/negative/02/data/sv.csv b/Published/CORE-000039/positive/02/data/sv.csv similarity index 81% rename from Published/CORE-000039/negative/02/data/sv.csv rename to Published/CORE-000039/positive/02/data/sv.csv index b7227b07b..ff7332b94 100644 --- a/Published/CORE-000039/negative/02/data/sv.csv +++ b/Published/CORE-000039/positive/02/data/sv.csv @@ -1,11 +1,11 @@ -STUDYID,DOMAIN,USUBJID,VISITNUM,VISIT,VISITDY,SVSTDTC,SVENDTC,SVSTDY,SVENDY,SVUPDES,SVPRESP -CDISCPILOT01,SV,CDISC001,12,SCREENING 1,-28,2012-11-23,2012-11-23,-7,-7,, -CDISCPILOT01,SV,CDISC001,13,SCREENING 2,-3,2012-11-28,2012-11-28,-2,-2,, -CDISCPILOT01,SV,CDISC001,14,BASELINE,1,2012-11-30,2012-11-30,1,1,,Y -CDISCPILOT01,SV,CDISC001,15,WEEK 2,15,2012-12-13,2012-12-13,14,14,,Y -CDISCPILOT01,SV,CDISC001,16,WEEK 4,29,2012-12-26,2012-12-26,27,27,,Y -CDISCPILOT01,SV,CDISC001,5.01,WEEK 4: UNSCHEDULED 01,,2012-12-28,2012-12-28,29,29,UNSCHEDULED LABS,Y -CDISCPILOT01,SV,CDISC001,17,WEEK 6,43,2013-01-10,2013-01-10,42,42,,Y -CDISCPILOT01,SV,CDISC001,19,WEEK 8,57,2013-01-23,2013-01-23,55,55,,Y -CDISCPILOT01,SV,CDISC001,101,EARLY DISCONTINUATION,,2013-02-14,2013-02-14,77,77,,Y -CDISCPILOT01,SV,CDISC001,201,EARLY DISCONTINUATION RETRIEVAL,,2013-05-20,2013-05-20,172,172,,Y +STUDYID,DOMAIN,USUBJID,VISITNUM,VISIT,VISITDY,SVSTDTC,SVENDTC,SVSTDY,SVENDY,SVUPDES +CDISCPILOT01,SV,CDISC001,12,SCREENING 1,-28,2012-11-23,2012-11-23,-7,-7, +CDISCPILOT01,SV,CDISC001,13,SCREENING 2,-3,2012-11-28,2012-11-28,-2,-2, +CDISCPILOT01,SV,CDISC001,14,BASELINE,1,2012-11-30,2012-11-30,1,1, +CDISCPILOT01,SV,CDISC001,15,WEEK 2,15,2012-12-13,2012-12-13,14,14, +CDISCPILOT01,SV,CDISC001,16,WEEK 4,29,2012-12-26,2012-12-26,27,27, +CDISCPILOT01,SV,CDISC001,5.01,WEEK 4: UNSCHEDULED 01,,2012-12-28,2012-12-28,29,29,UNSCHEDULED LABS +CDISCPILOT01,SV,CDISC001,17,WEEK 6,43,2013-01-10,2013-01-10,42,42, +CDISCPILOT01,SV,CDISC001,19,WEEK 8,57,2013-01-23,2013-01-23,55,55, +CDISCPILOT01,SV,CDISC001,101,EARLY DISCONTINUATION,,2013-02-14,2013-02-14,77,77, +CDISCPILOT01,SV,CDISC001,201,EARLY DISCONTINUATION RETRIEVAL,,2013-05-20,2013-05-20,172,172, diff --git a/Published/CORE-000039/negative/02/data/tv.csv b/Published/CORE-000039/positive/02/data/tv.csv similarity index 100% rename from Published/CORE-000039/negative/02/data/tv.csv rename to Published/CORE-000039/positive/02/data/tv.csv diff --git a/Published/CORE-000039/positive/02/results/results.csv b/Published/CORE-000039/positive/02/results/results.csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Published/CORE-000039/positive/02/results/results.csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value From aa21a14790e5142cb6adb1e4ee906a435df53587 Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Fri, 10 Jul 2026 10:14:39 -0400 Subject: [PATCH 02/13] Fix for CORE-000047 --- Published/CORE-000047/rule.yml | 2 -- 1 file changed, 2 deletions(-) diff --git a/Published/CORE-000047/rule.yml b/Published/CORE-000047/rule.yml index c4ea2ffd9..0e87d89ea 100644 --- a/Published/CORE-000047/rule.yml +++ b/Published/CORE-000047/rule.yml @@ -84,8 +84,6 @@ Outcome: Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study is a multistage assignment study - Output Variables: - - ARM Rule Type: Record Data Scope: Classes: From e53320b6e40a3c3c92562a3ade2a2a2fbedca7bd Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Fri, 10 Jul 2026 10:17:16 -0400 Subject: [PATCH 03/13] sort/format --- Published/CORE-000047/rule.yml | 142 ++++++++++++++++----------------- 1 file changed, 67 insertions(+), 75 deletions(-) diff --git a/Published/CORE-000047/rule.yml b/Published/CORE-000047/rule.yml index 0e87d89ea..0e64ef7cf 100644 --- a/Published/CORE-000047/rule.yml +++ b/Published/CORE-000047/rule.yml @@ -2,95 +2,87 @@ # Condition: Study does not use multi-stage arm assignments and ACTARM ^= null # Rule: ARM in TA.ARM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm or followed a course - not described by any planned arm, ARM is null and ARMNRS is - populated." - Document: SDTMIG v3.4 - Item: Specification and ACTARM CDISC Notes - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0518 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0518 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm or followed a course - not described by any planned arm, ARM is null and ARMNRS is - populated. - Document: TIG 1.0 - Item: Specification:ARM - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0613 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be a + value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or followed + a course not described by any planned arm, ARM is null and ARMNRS is populated." + Document: SDTMIG v3.4 + Item: Specification and ACTARM CDISC Notes + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0518 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be a + value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or followed + a course not described by any planned arm, ACTARMCD is null and ARMNRS is populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0518 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be a + value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or followed + a course not described by any planned arm, ARM is null and ARMNRS is populated. + Document: TIG 1.0 + Item: Specification:ARM + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0613 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARM - operator: non_empty - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - name: ACTARM + operator: non_empty + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000047 Status: Published Version: '1' -Description: When study does not use multi-stage arm assignments and ARM is - populated, ARM must be present in TA.ARM. This rule has been executed to - identify all cases when ARM is not present in TA.ARM and therefore - acknowledges that false positives may be recorded when multi-stage arm - assignments are in use. +Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be present + in TA.ARM. This rule has been executed to identify all cases when ARM is not present in TA.ARM and therefore + acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: - - domain: TA - id: $ta_arm - name: ARM - operator: distinct +- domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: - Message: ARM value in DM dataset is not among the values of ARM variable in TA - dataset. This is allowed only in a multistage study with incomplete ARM - assignment. Please confirm if your study is a multistage assignment study + Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is allowed + only in a multistage study with incomplete ARM assignment. Please confirm if your study is a multistage + assignment study Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record From a0c34cb0aa4dbcdda732eeb32c2c6e3a9351f1c9 Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Fri, 10 Jul 2026 10:54:49 -0400 Subject: [PATCH 04/13] CORE-000092 --- Published/CORE-000092/negative/01/data/ec.csv | 2 +- .../CORE-000092/negative/01/results/results.csv | 14 +++++++------- 2 files changed, 8 insertions(+), 8 deletions(-) diff --git a/Published/CORE-000092/negative/01/data/ec.csv b/Published/CORE-000092/negative/01/data/ec.csv index b925b2d0b..0ae09993e 100644 --- a/Published/CORE-000092/negative/01/data/ec.csv +++ b/Published/CORE-000092/negative/01/data/ec.csv @@ -1,4 +1,4 @@ -Study Identifier,Domain Abbreviation,Unique Subject Identifier,Sequence Number,Link ID,Name of Treatment,Pre-Specified,Occurrence,Reason for Occur Value,Dose,Dose Description,Dose Units,Dose Form,Start Date/Time of Treatment,End Date/Time of Treatment,Study Day of Start of Treatment,Study Day of End of Treatment +STUDYID,DOMAIN,USUBJID,ECSEQ,ECLNKID,ECTRT,ECPRESP,ECOCCUR,ECREASOC,ECDOSE,ECDOSTXT,ECDOSU,ECDOSFRM,ECSTDTC,ECENDTC,ECSTDY,ECENDY ABC,EC,ABC1001,1,A2-20110114,BOTTLE A,Y,Y,,2,,TABLET,QD,2011-01-14 00:00:00,2011-01-28 00:00:00,1,15 ABC,EC,ABC2001,1,A2-20110114,BOTTLE A,Y,Y,,2,2-3,TABLET,QD,2011-01-14 00:00:00,2011-01-23 00:00:00,1,10 ABC,EC,ABC2001,2,A0-20110124,BOTTLE A,Y,N,PATIENT MISTAKE,,,TABLET,QD,2011-01-24 00:00:00,2011-01-24 00:00:00,11,11 diff --git a/Published/CORE-000092/negative/01/results/results.csv b/Published/CORE-000092/negative/01/results/results.csv index 98043ec0b..d1d1ff3c0 100644 --- a/Published/CORE-000092/negative/01/results/results.csv +++ b/Published/CORE-000092/negative/01/results/results.csv @@ -1,15 +1,15 @@ Dataset,Record,Variable,Value -AG,2,AGDOSE,250 +AG,2,AGDOSE,250.0 AG,2,AGDOSTXT,250-300 -CM,2,CMDOSE,100 +CM,2,CMDOSE,100.0 CM,2,CMDOSTXT,100-120 -EC,2,ECDOSE,2 +EC,2,ECDOSE,2.0 EC,2,ECDOSTXT,2-3 -EX,2,EXDOSE,500 +EX,2,EXDOSE,500.0 EX,2,EXDOSTXT,500-600 -ML,2,MLDOSE,8 +ML,2,MLDOSE,8.0 ML,2,MLDOSTXT,8 -PR,2,PRDOSE,25 +PR,2,PRDOSE,25.0 PR,2,PRDOSTXT,25-30 -SU,2,SUDOSE,3 +SU,2,SUDOSE,3.0 SU,2,SUDOSTXT,3-4 From 2142aeb15d00400d958340930732fdc7e0e27809 Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Fri, 10 Jul 2026 11:00:08 -0400 Subject: [PATCH 05/13] CORE-000047 ruamel formatting --- Published/CORE-000047/rule.yml | 32 +++++++++++++++++--------------- 1 file changed, 17 insertions(+), 15 deletions(-) diff --git a/Published/CORE-000047/rule.yml b/Published/CORE-000047/rule.yml index 0e64ef7cf..91e911edb 100644 --- a/Published/CORE-000047/rule.yml +++ b/Published/CORE-000047/rule.yml @@ -7,9 +7,9 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be a - value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned arm, ARM is null and ARMNRS is populated." + - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated." Document: SDTMIG v3.4 Item: Specification and ACTARM CDISC Notes Section: '5.2' @@ -22,9 +22,10 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be a - value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null and ARMNRS is populated. + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. Document: IG v3.3 Item: Specification Section: '5.2' @@ -37,9 +38,9 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be a - value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned arm, ARM is null and ARMNRS is populated. + - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated. Document: TIG 1.0 Item: Specification:ARM Section: 2.8.10.4 @@ -63,9 +64,10 @@ Core: Id: CORE-000047 Status: Published Version: '1' -Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be present - in TA.ARM. This rule has been executed to identify all cases when ARM is not present in TA.ARM and therefore - acknowledges that false positives may be recorded when multi-stage arm assignments are in use. +Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be + present in TA.ARM. This rule has been executed to identify all cases when ARM is not present in + TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm + assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: - domain: TA @@ -73,9 +75,9 @@ Operations: name: ARM operator: distinct Outcome: - Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is allowed - only in a multistage study with incomplete ARM assignment. Please confirm if your study is a multistage - assignment study + Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is + allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study + is a multistage assignment study Rule Type: Record Data Scope: Classes: From 665143a3dba37130c41a2c4d25dc45024ddab49d Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Fri, 10 Jul 2026 13:58:17 -0400 Subject: [PATCH 06/13] CORE-000093 --- .../negative/01/data/_variables.csv | 17 +++++++++++++++++ Published/CORE-000093/negative/01/data/ec.csv | 5 +---- .../negative/01/results/results.csv | 18 +++++++++--------- 3 files changed, 27 insertions(+), 13 deletions(-) diff --git a/Published/CORE-000093/negative/01/data/_variables.csv b/Published/CORE-000093/negative/01/data/_variables.csv index e3abeb403..07e1f099b 100644 --- a/Published/CORE-000093/negative/01/data/_variables.csv +++ b/Published/CORE-000093/negative/01/data/_variables.csv @@ -24,6 +24,23 @@ cm,CMDOSFRQ,Dosing Frequency per Interval,Char,50 cm,CMDOSTOT,Total Daily Dose,Num,8 cm,CMSTDTC,Start Date/Time of Medication,Char,50 cm,CMENDTC,End Date/Time of Medication,Char,50 +ec,STUDYID,Study Identifier,Char,50 +ec,DOMAIN,Domain Abbreviation,Char,50 +ec,USUBJID,Unique Subject Identifier,Char,50 +ec,ECSEQ,Sequence Number,Num,8 +ec,ECLNKID,Link ID,Char,50 +ec,ECTRT,Name of Treatment,Char,50 +ec,ECPRESP,Pre-Specified,Char,50 +ec,ECOCCUR,Occurrence,Char,50 +ec,ECREASOC,Reason for Occur Value,Char,50 +ec,ECDOSE,Dose,Num,8 +ec,ECDOSTXT,Dose Description,Char,50 +ec,ECDOSU,Dose Units,Char,50 +ec,ECDOSFRM,Dose Form,Char,50 +ec,ECSTDTC,Start Date/Time of Treatment,Char,50 +ec,ECENDTC,End Date/Time of Treatment,Char,50 +ec,ECSTDY,Study Day of Start of Treatment,Num,8 +ec,ECENDY,Study Day of End of Treatment,Num,8 ex,STUDYID,Study Identifier,Char,50 ex,DOMAIN,Domain Abbreviation,Char,50 ex,USUBJID,Unique Subject Identifier,Char,50 diff --git a/Published/CORE-000093/negative/01/data/ec.csv b/Published/CORE-000093/negative/01/data/ec.csv index a254912c9..c22e1844e 100644 --- a/Published/CORE-000093/negative/01/data/ec.csv +++ b/Published/CORE-000093/negative/01/data/ec.csv @@ -1,7 +1,4 @@ -,,,,,,,,,,,,,,,, -Study Identifier,Domain Abbreviation,Unique Subject Identifier,Sequence Number,Link ID,Name of Treatment,Pre-Specified,Occurrence,Reason for Occur Value,Dose,Dose Description,Dose Units,Dose Form,Start Date/Time of Treatment,End Date/Time of Treatment,Study Day of Start of Treatment,Study Day of End of Treatment -Char,Char,Char,Num,Char,Char,Char,Char,Char,Num,Char,Char,Char,Char,Char,Num,Num -50,50,50,8,50,50,50,50,50,8,50,50,50,50,50,8,8 +STUDYID,DOMAIN,USUBJID,ECSEQ,ECLNKID,ECTRT,ECPRESP,ECOCCUR,ECREASOC,ECDOSE,ECDOSTXT,ECDOSU,ECDOSFRM,ECSTDTC,ECENDTC,ECSTDY,ECENDY ABC,EC,ABC1001,1,A2-20110114,BOTTLE A,Y,Y,,2,,TABLET,QD,2011-01-14 00:00:00,2011-01-28 00:00:00,1,15 ABC,EC,ABC2001,1,A2-20110114,BOTTLE A,Y,Y,,2,,,QD,2011-01-14 00:00:00,2011-01-23 00:00:00,1,10 ABC,EC,ABC2001,2,A0-20110124,BOTTLE A,Y,N,PATIENT MISTAKE,,,TABLET,QD,2011-01-24 00:00:00,2011-01-24 00:00:00,11,11 diff --git a/Published/CORE-000093/negative/01/results/results.csv b/Published/CORE-000093/negative/01/results/results.csv index 1d74b123c..025a4aacc 100644 --- a/Published/CORE-000093/negative/01/results/results.csv +++ b/Published/CORE-000093/negative/01/results/results.csv @@ -1,17 +1,17 @@ Dataset,Record,Variable,Value -AG,1,AGDOSTOT,Not in dataset -AG,2,AGDOSE,250 +AG,2,AGDOSE,250.0 +AG,2,AGDOSTOT,Not in dataset AG,2,AGDOSTXT, AG,2,AGDOSU, -CM,2,CMDOSE,100 -CM,2,CMDOSTOT,200 +CM,2,CMDOSE,100.0 +CM,2,CMDOSTOT,200.0 CM,2,CMDOSTXT, CM,2,CMDOSU, -EC,1,ECDOSTOT,Not in dataset -EC,2,ECDOSE,2 +EC,2,ECDOSE,2.0 +EC,2,ECDOSTOT,Not in dataset EC,2,ECDOSTXT, EC,2,ECDOSU, -EX,1,EXDOSE,1000 +EX,1,EXDOSE,1000.0 EX,1,EXDOSTOT,Not in dataset EX,1,EXDOSTXT, EX,1,EXDOSU, @@ -19,11 +19,11 @@ ML,1,MLDOSE, ML,1,MLDOSTOT,Not in dataset ML,1,MLDOSTXT,2 ML,1,MLDOSU, -PR,1,PRDOSE,70 +PR,1,PRDOSE,70.0 PR,1,PRDOSTOT,Not in dataset PR,1,PRDOSTXT, PR,1,PRDOSU, SU,2,SUDOSE, -SU,2,SUDOSTOT,3 +SU,2,SUDOSTOT,3.0 SU,2,SUDOSTXT, SU,2,SUDOSU, From 39bf1420268def8d309eec7600f019d04aed2488 Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Fri, 10 Jul 2026 14:17:06 -0400 Subject: [PATCH 07/13] CORE-000093 positive --- .../CORE-000093/positive/01/data/_variables.csv | 17 +++++++++++++++++ Published/CORE-000093/positive/01/data/ec.csv | 5 +---- .../CORE-000093/positive/01/results/results.csv | 5 ----- 3 files changed, 18 insertions(+), 9 deletions(-) diff --git a/Published/CORE-000093/positive/01/data/_variables.csv b/Published/CORE-000093/positive/01/data/_variables.csv index e3abeb403..07e1f099b 100644 --- a/Published/CORE-000093/positive/01/data/_variables.csv +++ b/Published/CORE-000093/positive/01/data/_variables.csv @@ -24,6 +24,23 @@ cm,CMDOSFRQ,Dosing Frequency per Interval,Char,50 cm,CMDOSTOT,Total Daily Dose,Num,8 cm,CMSTDTC,Start Date/Time of Medication,Char,50 cm,CMENDTC,End Date/Time of Medication,Char,50 +ec,STUDYID,Study Identifier,Char,50 +ec,DOMAIN,Domain Abbreviation,Char,50 +ec,USUBJID,Unique Subject Identifier,Char,50 +ec,ECSEQ,Sequence Number,Num,8 +ec,ECLNKID,Link ID,Char,50 +ec,ECTRT,Name of Treatment,Char,50 +ec,ECPRESP,Pre-Specified,Char,50 +ec,ECOCCUR,Occurrence,Char,50 +ec,ECREASOC,Reason for Occur Value,Char,50 +ec,ECDOSE,Dose,Num,8 +ec,ECDOSTXT,Dose Description,Char,50 +ec,ECDOSU,Dose Units,Char,50 +ec,ECDOSFRM,Dose Form,Char,50 +ec,ECSTDTC,Start Date/Time of Treatment,Char,50 +ec,ECENDTC,End Date/Time of Treatment,Char,50 +ec,ECSTDY,Study Day of Start of Treatment,Num,8 +ec,ECENDY,Study Day of End of Treatment,Num,8 ex,STUDYID,Study Identifier,Char,50 ex,DOMAIN,Domain Abbreviation,Char,50 ex,USUBJID,Unique Subject Identifier,Char,50 diff --git a/Published/CORE-000093/positive/01/data/ec.csv b/Published/CORE-000093/positive/01/data/ec.csv index 872a42edf..31873e57f 100644 --- a/Published/CORE-000093/positive/01/data/ec.csv +++ b/Published/CORE-000093/positive/01/data/ec.csv @@ -1,7 +1,4 @@ -,,,,,,,,,,,,,,,, -Study Identifier,Domain Abbreviation,Unique Subject Identifier,Sequence Number,Link ID,Name of Treatment,Pre-Specified,Occurrence,Reason for Occur Value,Dose,Dose Description,Dose Units,Dose Form,Start Date/Time of Treatment,End Date/Time of Treatment,Study Day of Start of Treatment,Study Day of End of Treatment -Char,Char,Char,Num,Char,Char,Char,Char,Char,Num,Char,Char,Char,Char,Char,Num,Num -50,50,50,8,50,50,50,50,50,8,50,50,50,50,50,8,8 +STUDYID,DOMAIN,USUBJID,ECSEQ,ECLNKID,ECTRT,ECPRESP,ECOCCUR,ECREASOC,ECDOSE,ECDOSTXT,ECDOSU,ECDOSFRM,ECSTDTC,ECENDTC,ECSTDY,ECENDY ABC,EC,ABC1001,1,A2-20110114,BOTTLE A,Y,Y,,2,,TABLET,QD,2011-01-14 00:00:00,2011-01-28 00:00:00,1,15 ABC,EC,ABC2001,1,A2-20110114,BOTTLE A,Y,Y,,2,,TABLET,QD,2011-01-14 00:00:00,2011-01-23 00:00:00,1,10 ABC,EC,ABC2001,2,A0-20110124,BOTTLE A,Y,N,PATIENT MISTAKE,,,TABLET,QD,2011-01-24 00:00:00,2011-01-24 00:00:00,11,11 diff --git a/Published/CORE-000093/positive/01/results/results.csv b/Published/CORE-000093/positive/01/results/results.csv index 9e550c43e..a13018c5f 100644 --- a/Published/CORE-000093/positive/01/results/results.csv +++ b/Published/CORE-000093/positive/01/results/results.csv @@ -1,6 +1 @@ Dataset,Record,Variable,Value -AG,,, -EC,,, -EX,,, -ML,,, -PR,,, From 481cf3f65812813c2cb9358650df6c43bd47d7c0 Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Fri, 10 Jul 2026 14:30:25 -0400 Subject: [PATCH 08/13] CORE-000097 --- .../negative/01/results/results.csv | 7 +++ Published/CORE-000097/rule.yml | 48 +++++++++++-------- 2 files changed, 36 insertions(+), 19 deletions(-) create mode 100644 Published/CORE-000097/negative/01/results/results.csv diff --git a/Published/CORE-000097/negative/01/results/results.csv b/Published/CORE-000097/negative/01/results/results.csv new file mode 100644 index 000000000..03baa4226 --- /dev/null +++ b/Published/CORE-000097/negative/01/results/results.csv @@ -0,0 +1,7 @@ +Dataset,Record,Variable,Value +SV,5,EPOCH,SCREENING +SV,5,SE.EPOCH,"OPEN LABEL +TREATMENT" +SV,5,SEENDTC,2019-05-13 +SV,5,SESTDTC,2018-08-13 +SV,5,SVSTDTC,2018-08-20 diff --git a/Published/CORE-000097/rule.yml b/Published/CORE-000097/rule.yml index 48327a98e..20cfcc3bf 100644 --- a/Published/CORE-000097/rule.yml +++ b/Published/CORE-000097/rule.yml @@ -7,21 +7,23 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the start of the visit. Document: IG v3.4 Item: Assumption 11 - Section: '5.5' + Section: "5.5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the start of the visit.It would be inappropriate to add the variables that support time points (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is @@ -32,30 +34,32 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the start of the visit.It would be inappropriate to add the variables that support time points (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is visits. Document: IG v3.3 Item: Assumption 11 - Section: '5.5' + Section: "5.5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: TIG References: - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the start of the visit. Document: TIG 1.0 Item: Assumption 11 @@ -63,10 +67,10 @@ Authorities: Origin: TIG Conformance Rules Rule Identifier: Id: TIG0432 - Version: '1' - Version: '1.0' + Version: "1" + Version: "1.0" Substandard: SDTM - Version: '1.0' + Version: "1.0" Check: all: - name: EPOCH @@ -83,7 +87,7 @@ Check: Core: Id: CORE-000097 Status: Published - Version: '1' + Version: "1" Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Executability: Partially Executable - Possible Overreporting @@ -94,6 +98,12 @@ Match Datasets: Outcome: Message: EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. + Output Variables: + - SESTDTC + - SVSTDTC + - SEENDTC + - EPOCH + - SE.EPOCH Rule Type: Record Data Scope: Classes: From f829a8378a8d0fe05c9ea11020e5c2a3c1978453 Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Wed, 15 Jul 2026 11:37:21 -0400 Subject: [PATCH 09/13] 97 formatting --- Published/CORE-000097/rule.yml | 181 ++++++++++++++++----------------- 1 file changed, 87 insertions(+), 94 deletions(-) diff --git a/Published/CORE-000097/rule.yml b/Published/CORE-000097/rule.yml index 20cfcc3bf..76bdd88b1 100644 --- a/Published/CORE-000097/rule.yml +++ b/Published/CORE-000097/rule.yml @@ -2,115 +2,108 @@ # Condition: EPOCH present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <= SEENDTC # Rule: EPOCH = SE.EPOCH Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: - If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit. - Document: IG v3.4 - Item: Assumption 11 - Section: "5.5" - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: "1" - Version: "2.0" - Version: "3.4" - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: - If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit.It would be inappropriate to add the - variables that support time points (--TPT, --TPTNUM, --ELTM, - --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.2 - Item: Assumption 11 - Section: 5 SV - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: "1" - Version: "2.0" - Version: "3.2" - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: - If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit.It would be inappropriate to add the - variables that support time points (--TPT, --TPTNUM, --ELTM, - --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.3 - Item: Assumption 11 - Section: "5.5" - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: "1" - Version: "2.0" - Version: "3.3" - - Name: TIG - References: - - Citations: - - Cited Guidance: - If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit. - Document: TIG 1.0 - Item: Assumption 11 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0432 - Version: "1" - Version: "1.0" - Substandard: SDTM - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: IG v3.4 + Item: Assumption 11 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.2 + Item: Assumption 11 + Section: 5 SV + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.3 + Item: Assumption 11 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: TIG 1.0 + Item: Assumption 11 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0432 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: EPOCH - operator: exists - - name: SESTDTC - operator: date_less_than_or_equal_to - value: SVSTDTC - - name: SVSTDTC - operator: date_less_than_or_equal_to - value: SEENDTC - - name: EPOCH - operator: not_equal_to - value: SE.EPOCH + - name: EPOCH + operator: exists + - name: SESTDTC + operator: date_less_than_or_equal_to + value: SVSTDTC + - name: SVSTDTC + operator: date_less_than_or_equal_to + value: SEENDTC + - name: EPOCH + operator: not_equal_to + value: SE.EPOCH Core: Id: CORE-000097 Status: Published Version: "1" -Description: Raise an error when variable EPOCH values don't match between - Subject Visits (SV) and Subject Elements (SE) datasets. +Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and + Subject Elements (SE) datasets. Executability: Partially Executable - Possible Overreporting Match Datasets: - - Keys: - - USUBJID - Name: SE +- Keys: + - USUBJID + Name: SE Outcome: - Message: EPOCH values don't match between Subject Visits (SV) and Subject - Elements (SE) datasets. + Message: EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Output Variables: - - SESTDTC - - SVSTDTC - - SEENDTC - - EPOCH - - SE.EPOCH + - SESTDTC + - SVSTDTC + - SEENDTC + - EPOCH + - SE.EPOCH Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record From dfa98653ff6084e879a62635c2cdf19c447e660b Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Wed, 15 Jul 2026 12:24:22 -0400 Subject: [PATCH 10/13] CORE-000118 --- .../negative/01/results/results.csv | 14 +- Published/CORE-000118/rule.yml | 275 ++++++++---------- 2 files changed, 132 insertions(+), 157 deletions(-) diff --git a/Published/CORE-000118/negative/01/results/results.csv b/Published/CORE-000118/negative/01/results/results.csv index 21621c603..ce67153fb 100644 --- a/Published/CORE-000118/negative/01/results/results.csv +++ b/Published/CORE-000118/negative/01/results/results.csv @@ -1,9 +1,7 @@ Dataset,Record,Variable,Value -CM,2,CMOCCUR, -CM,2,CMPRESP,Y -CM,3,CMOCCUR, -CM,3,CMPRESP,Y -MH,3,MHOCCUR, -MH,3,MHPRESP,Y -MH,4,MHOCCUR, -MH,4,MHPRESP,Y +CM,,CMOCCUR, +CM,,CMPRESP,Y +CM,,CMSTAT,Not in dataset +MH,,MHOCCUR, +MH,,MHPRESP,Y +MH,,MHSTAT,Not in dataset diff --git a/Published/CORE-000118/rule.yml b/Published/CORE-000118/rule.yml index 78443f33d..1c10bb5a2 100644 --- a/Published/CORE-000118/rule.yml +++ b/Published/CORE-000118/rule.yml @@ -2,168 +2,145 @@ # Condition: --PRESP = 'Y' and --OCCUR = null # Rule: --STAT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or - detailed on the CRF - Document: SDTM v2.0 - Item: --PRESP - Section: Events - - Cited Guidance: An indication as to whether a prespecified event has occurred - Document: SDTM v2.0 - Item: --OCCUR - Section: Events - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of 'NOT DONE' - Document: Model v2.0 - Item: --STAT - Section: Events - - Cited Guidance: An indication that the intervention was prospectively stated or - detailed on the CRF - Document: Model v2.0 - Item: --PRESP - Section: Interventions - - Cited Guidance: An indication as to whether a prespecified intervention has - occurred. - Document: Model v2.0 - Item: --OCCUR - Section: Interventions - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified intervention was not answered. Should be null or - have a value of 'NOT DONE' - Document: Model v2.0 - Item: --STAT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be 'Y' or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or have a - value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events; - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or have a value of NOT DONE]" - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be 'Y' or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or have a - value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events; - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or have a value of NOT DONE]" - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or - detailed on the CRF | An indication that the intervention was - prospectively stated or detailed on the CRF. - Document: SDTM v2.1 - Item: --PRESP - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The - Findings Observation Class - - Cited Guidance: An indication as to whether a prespecified event has occurred. | - An indication as to whether a prespecified intervention has - occurred - Document: SDTM v2.1 - Item: --OCCUR - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The - Findings Observation Class - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE" | Used to indicate when a question about - the occurrence of a prespecified intervention was not - answered. Should be null or have a value of "NOT DONE". - Document: SDTM v2.1 - Item: --STAT - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The - Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0562 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF + Document: SDTM v2.0 + Item: --PRESP + Section: Events + - Cited Guidance: An indication as to whether a prespecified event has occurred + Document: SDTM v2.0 + Item: --OCCUR + Section: Events + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + event was not answered. Should be null or have a value of 'NOT DONE' + Document: Model v2.0 + Item: --STAT + Section: Events + - Cited Guidance: An indication that the intervention was prospectively stated or detailed on + the CRF + Document: Model v2.0 + Item: --PRESP + Section: Interventions + - Cited Guidance: An indication as to whether a prespecified intervention has occurred. + Document: Model v2.0 + Item: --OCCUR + Section: Interventions + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + intervention was not answered. Should be null or have a value of 'NOT DONE' + Document: Model v2.0 + Item: --STAT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]" + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]" + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF + | An indication that the intervention was prospectively stated or detailed on the CRF. + Document: SDTM v2.1 + Item: --PRESP + Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + - Cited Guidance: An indication as to whether a prespecified event has occurred. | An + indication as to whether a prespecified intervention has occurred + Document: SDTM v2.1 + Item: --OCCUR + Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + event was not answered. Should be null or have a value of "NOT DONE" | Used to indicate + when a question about the occurrence of a prespecified intervention was not answered. + Should be null or have a value of "NOT DONE". + Document: SDTM v2.1 + Item: --STAT + Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0562 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: equal_to - value: Y - - name: --OCCUR - operator: empty - - name: --STAT - operator: not_exists + - name: --PRESP + operator: equal_to + value: Y + - name: --OCCUR + operator: empty + - name: --STAT + operator: not_exists Core: Id: CORE-000118 Status: Published - Version: '1' -Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty - and --STAT is not present in dataset. + Version: "1" +Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not + present in dataset. Executability: Fully Executable Outcome: - Message: --STAT is not present in dataset when --PRESP is equal to "Y" and - --OCCUR is blank - Output Variables: - - --PRESP - - --OCCUR + Message: --STAT is not present in dataset when --PRESP is equal to "Y" and --OCCUR is blank Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset From 085c34749025c482091f55b04d136c283ed894cb Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Wed, 15 Jul 2026 12:32:14 -0400 Subject: [PATCH 11/13] CORE-000118 --- .../negative/01/results/results.csv | 18 ++++++++++++------ Published/CORE-000118/rule.yml | 2 +- 2 files changed, 13 insertions(+), 7 deletions(-) diff --git a/Published/CORE-000118/negative/01/results/results.csv b/Published/CORE-000118/negative/01/results/results.csv index ce67153fb..b3d93eecf 100644 --- a/Published/CORE-000118/negative/01/results/results.csv +++ b/Published/CORE-000118/negative/01/results/results.csv @@ -1,7 +1,13 @@ Dataset,Record,Variable,Value -CM,,CMOCCUR, -CM,,CMPRESP,Y -CM,,CMSTAT,Not in dataset -MH,,MHOCCUR, -MH,,MHPRESP,Y -MH,,MHSTAT,Not in dataset +CM,2,CMOCCUR, +CM,2,CMPRESP,Y +CM,2,CMSTAT,Not in dataset +CM,3,CMOCCUR, +CM,3,CMPRESP,Y +CM,3,CMSTAT,Not in dataset +MH,3,MHOCCUR, +MH,3,MHPRESP,Y +MH,3,MHSTAT,Not in dataset +MH,4,MHOCCUR, +MH,4,MHPRESP,Y +MH,4,MHSTAT,Not in dataset diff --git a/Published/CORE-000118/rule.yml b/Published/CORE-000118/rule.yml index 1c10bb5a2..77e23ded7 100644 --- a/Published/CORE-000118/rule.yml +++ b/Published/CORE-000118/rule.yml @@ -143,4 +143,4 @@ Scope: - DV - EX Use Case: INDH, PROD -Sensitivity: Dataset +Sensitivity: Record From bd5b5a0ecb061bb20835568700c34c427783bd5e Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Wed, 15 Jul 2026 12:43:03 -0400 Subject: [PATCH 12/13] CORE-000132 --- Published/CORE-000132/negative/01/data/.env | 2 +- Published/CORE-000132/negative/01/results/results.csv | 11 +++++++++++ 2 files changed, 12 insertions(+), 1 deletion(-) create mode 100644 Published/CORE-000132/negative/01/results/results.csv diff --git a/Published/CORE-000132/negative/01/data/.env b/Published/CORE-000132/negative/01/data/.env index 1f7a788c6..8f9bf60aa 100644 --- a/Published/CORE-000132/negative/01/data/.env +++ b/Published/CORE-000132/negative/01/data/.env @@ -1,2 +1,2 @@ -PRODUCT=SENDIG +PRODUCT=SDTMIG VERSION=3-4 diff --git a/Published/CORE-000132/negative/01/results/results.csv b/Published/CORE-000132/negative/01/results/results.csv new file mode 100644 index 000000000..0b7d6a26f --- /dev/null +++ b/Published/CORE-000132/negative/01/results/results.csv @@ -0,0 +1,11 @@ +Dataset,Record,Variable,Value +TA,1,ELEMENT, +TA,1,ETCD,SCREEN +TA,3,ELEMENT,Screening +TA,3,ETCD,SCREEN +TA,5,ELEMENT,Screening +TA,5,ETCD,SCREEN +TE,3,ELEMENT,Zanomaline 54 mg +TE,3,ETCD,LOW +TE,6,ELEMENT,Zanomaline 40 mg +TE,6,ETCD,LOW From 81305c95b82856ff130c6eb7babcdadf9344d117 Mon Sep 17 00:00:00 2001 From: Gerry Campion Date: Wed, 15 Jul 2026 13:44:04 -0400 Subject: [PATCH 13/13] CORE-000141 --- .../negative/01/results/results.csv | 6 + .../negative/02/results/results.csv | 18 +- Published/CORE-000141/rule.yml | 262 +++++++++--------- 3 files changed, 146 insertions(+), 140 deletions(-) diff --git a/Published/CORE-000141/negative/01/results/results.csv b/Published/CORE-000141/negative/01/results/results.csv index 328d49abe..ba0cdb871 100644 --- a/Published/CORE-000141/negative/01/results/results.csv +++ b/Published/CORE-000141/negative/01/results/results.csv @@ -1,7 +1,13 @@ Dataset,Record,Variable,Value FT,1,FTTPT,30 MIN POST FT,1,FTTPTNUM,30.0 +FT,1,FTTPTREF,Not in dataset +FT,1,VISITNUM,Not in dataset FT,2,FTTPT,30 MIN POST FT,2,FTTPTNUM,1.0 +FT,2,FTTPTREF,Not in dataset +FT,2,VISITNUM,Not in dataset FT,3,FTTPT,60 MIN POST FT,3,FTTPTNUM,1.0 +FT,3,FTTPTREF,Not in dataset +FT,3,VISITNUM,Not in dataset diff --git a/Published/CORE-000141/negative/02/results/results.csv b/Published/CORE-000141/negative/02/results/results.csv index 07ad0a32a..78f397bb6 100644 --- a/Published/CORE-000141/negative/02/results/results.csv +++ b/Published/CORE-000141/negative/02/results/results.csv @@ -1,13 +1,21 @@ Dataset,Record,Variable,Value +VS,1,VISITNUM,Not in dataset VS,1,VSTPT,10MIN POSTDOSE VS,1,VSTPTNUM, -VS,2,VSTPT, -VS,2,VSTPTNUM, +VS,1,VSTPTREF,Not in dataset +VS,3,VISITNUM,Not in dataset VS,3,VSTPT,PREDOSE VS,3,VSTPTNUM, +VS,3,VSTPTREF,Not in dataset +VS,4,VISITNUM,Not in dataset VS,4,VSTPT,PREDOSE -VS,4,VSTPTNUM,-1 +VS,4,VSTPTNUM,-1.0 +VS,4,VSTPTREF,Not in dataset +VS,5,VISITNUM,Not in dataset VS,5,VSTPT,10MIN POSTDOSE -VS,5,VSTPTNUM,5 +VS,5,VSTPTNUM,5.0 +VS,5,VSTPTREF,Not in dataset +VS,6,VISITNUM,Not in dataset VS,6,VSTPT,5MIN POSTDOSE -VS,6,VSTPTNUM,5 +VS,6,VSTPTNUM,5.0 +VS,6,VSTPTREF,Not in dataset diff --git a/Published/CORE-000141/rule.yml b/Published/CORE-000141/rule.yml index adcfac4eb..c6c96a6e3 100644 --- a/Published/CORE-000141/rule.yml +++ b/Published/CORE-000141/rule.yml @@ -2,156 +2,148 @@ # Condition: VISITNUM and --TPTREF are not present in dataset # Rule: --TPT and --TPTNUM have a one-to-one relationship Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - which may include domain, visit, and reference time point, - there must be a one-to-relationship between values of --TPT - and --TPTNUM. in other words, if domain, visit, and reference - time point uniquely identify subject data, then if two - subjects have records with the same values of DOMAIN, - VISITNUM, --TPTREF, and --TPTNUM, then these records may not - have different time point descriptions in --TPT. - Document: IG v3.4 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - which may include domain, visit, and reference time point, - there must be a one-to-relationship between values of --TPT - and --TPTNUM. in other words, if domain, visit, and reference - time point uniquely identify subject data, then if two - subjects have records with the same values of DOMAIN, - VISITNUM, --TPTREF, and --TPTNUM, then these records may not - have different time point descriptions in --TPT. - Document: IG v3.3 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - which may include domain, visit, and reference time point, - there must be a one-to-relationship between values of --TPT - and --TPTNUM. in other words, if domain, visit, and reference - time point uniquely identify subject data, then if two - subjects have records with the same values of DOMAIN, - VISITNUM, --TPTREF, and --TPTNUM, then these records may not - have different time point descriptions in --TPT. - Document: IG v3.2 - Section: 4.1.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Timepoints will be represented using both --TPT and --TPTNUM. - There will be a one-to-one relationship between the values of - --TPT and --TPTNUM. - Document: TIG 1.0 - Item: Sub Section Planned Timing Num 5 - Section: '2.8.7.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0448 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.4 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.3 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.2 + Section: 4.1.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Timepoints will be represented using both --TPT and --TPTNUM. There will be + a one-to-one relationship between the values of --TPT and --TPTNUM. + Document: TIG 1.0 + Item: Sub Section Planned Timing Num 5 + Section: '2.8.7.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0448 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: VISITNUM - operator: not_exists - - name: --TPTREF - operator: not_exists - - name: --TPT - operator: is_not_unique_relationship - value: --TPTNUM + - name: VISITNUM + operator: not_exists + - name: --TPTREF + operator: not_exists + - name: --TPT + operator: is_not_unique_relationship + value: --TPTNUM Core: Id: CORE-000141 Status: Published Version: '1' -Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM - should have a one-to-one relationship. +Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one + relationship. Executability: Fully Executable Outcome: Message: --TPT and --TPTNUM do not have a one-to-one relationship. Output Variables: - - --TPT - - --TPTNUM + - VISITNUM + - --TPTREF + - --TPT + - --TPTNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record