Non-results fixes

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

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

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

Published/CORE-000039/negative/02/data/_variables.csv → 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

Published/CORE-000039/negative/02/data/sv.csv → 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,

Published/CORE-000039/positive/02/results/results.csv

@@ -0,0 +1 @@
+Dataset,Record,Variable,Value

Published/CORE-000047/rule.yml

@@ -2,97 +2,89 @@
 # 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
+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
-  Output Variables:
-    - ARM
+  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

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

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

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

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

Published/CORE-000093/negative/01/results/results.csv

@@ -1,29 +1,29 @@
 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,
 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,

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