CORE-000106 fix

Published/CORE-000106/negative/01/data/.env

@@ -1,2 +1,2 @@
 PRODUCT=SDTMIG
-VERSION=3-4
+VERSION=3-4

Published/CORE-000106/negative/01/data/_datasets.csv

@@ -1,2 +1,3 @@
 Filename,Label
 cm,Concomitant/Prior Medications
+mh,Medical History

Published/CORE-000106/negative/01/data/_variables.csv

@@ -16,3 +16,15 @@ cm,CMSTDY,Study Day of Start of Medication,Num,8
 cm,CMENDY,Study Day of End of Medication,Num,8
 cm,CMENRTPT,End Relative to Reference Time Point,Char,7
 cm,CMENTPT,End Reference Time Point,Char,10
+mh,STUDYID,Study Identifier,Char,12
+mh,DOMAIN,Domain Abbreviation,Char,2
+mh,USUBJID,Unique Subject Identifier,Char,8
+mh,MHSEQ,Sequence Number,Num,8
+mh,MHTERM,Reported Term for the Medical History,Char,19
+mh,MHEVDTYP,Medical History Event Date Type,Char,13
+mh,MHSTDTC,Start Date/Time of Medical History Event,Char,10
+mh,MHSTDY,Study Day of Start of Observation,Num,8
+mh,MHENDTC,End Date/Time of Medical History Event,Char,50
+mh,MHENDY,Study Day of End of Observation,Num,8
+mh,MHENRTPT,End Relative to Reference Time Point,Char,50
+mh,MHENTPT,End Reference Time Point,Char,50

Published/CORE-000106/negative/01/data/cm.csv

@@ -9,4 +9,4 @@ CDISCPILOT01,CM,CDISC005,1,CENTRUM SILVER,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,T
 CDISCPILOT01,CM,CDISC005,4,HYDROCORTISONE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,TOPICAL,TREATMENT,2013-05-14,,100,,,2013-08-06
 CDISCPILOT01,CM,CDISC017,1,ACETAMINOPHEN,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2008,,,,,2014-03-08
 CDISCPILOT01,CM,CDISC017,2,MULTIVITAMIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2011-08,,,,,2014-03-08
-CDISCPILOT01,CM,CDISC017,3,VITAMIN E,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,2011-08,,,,,2014-03-08
+CDISCPILOT01,CM,CDISC017,3,VITAMIN E,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,2011-08,,,,,2014-03-08

Published/CORE-000106/negative/02/data/mh.csv → Published/CORE-000106/negative/01/data/mh.csv

@@ -6,4 +6,4 @@ CDISCPILOT01,MH,CDISC004,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-11-05,-1068,,,
 CDISCPILOT01,MH,CDISC005,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2006-08-20,-2360,,,,2000-06-11
 CDISCPILOT01,MH,CDISC006,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2008-06-17,-1736,,,,2021-05-01
 CDISCPILOT01,MH,CDISC007,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2008-05-21,-1690,2008-05-26,-1685,,2021-05-02
-CDISCPILOT01,MH,CDISC008,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2012-11-11,-546,2012-11-11,-546,,2021-11-23
+CDISCPILOT01,MH,CDISC008,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2012-11-11,-546,2012-11-11,-546,,2021-11-23

Published/CORE-000106/negative/01/results/results.csv

@@ -1,11 +1,27 @@
 Dataset,Record,Variable,Value
-CM.csv,6,CMENRTPT,
-CM.csv,6,CMENTPT,2013-08-06
-CM.csv,7,CMENRTPT,
-CM.csv,7,CMENTPT,2013-08-06
-CM.csv,8,CMENRTPT,
-CM.csv,8,CMENTPT,2014-03-08
-CM.csv,9,CMENRTPT,
-CM.csv,9,CMENTPT,2014-03-08
-CM.csv,10,CMENRTPT,
-CM.csv,10,CMENTPT,2014-03-08
+CM,7,CMENRTPT,null
+CM,7,CMENTPT,2013-08-06
+CM,8,CMENRTPT,null
+CM,8,CMENTPT,2013-08-06
+CM,9,CMENRTPT,null
+CM,9,CMENTPT,2014-03-08
+CM,10,CMENRTPT,null
+CM,10,CMENTPT,2014-03-08
+CM,11,CMENRTPT,null
+CM,11,CMENTPT,2014-03-08
+MH,1,MHENRTPT,null
+MH,1,MHENTPT,2021-05-01
+MH,2,MHENRTPT,null
+MH,2,MHENTPT,2021-02-15
+MH,3,MHENRTPT,null
+MH,3,MHENTPT,2015-05-09
+MH,4,MHENRTPT,null
+MH,4,MHENTPT,2011-06-11
+MH,5,MHENRTPT,null
+MH,5,MHENTPT,2000-06-11
+MH,6,MHENRTPT,null
+MH,6,MHENTPT,2021-05-01
+MH,7,MHENRTPT,null
+MH,7,MHENTPT,2021-05-02
+MH,8,MHENRTPT,null
+MH,8,MHENTPT,2021-11-23

Published/CORE-000106/positive/01/data/.env

@@ -1,2 +1,2 @@
 PRODUCT=SDTMIG
-VERSION=3-4
+VERSION=3-4

Published/CORE-000106/positive/01/data/_datasets.csv

@@ -1,2 +1,3 @@
 Filename,Label
 cm,Concomitant/Prior Medications
+mh,Medical History

Published/CORE-000106/positive/01/data/_variables.csv

@@ -16,3 +16,15 @@ cm,CMSTDY,Study Day of Start of Medication,Num,8
 cm,CMENDY,Study Day of End of Medication,Num,8
 cm,CMENRTPT,End Relative to Reference Time Point,Char,7
 cm,CMENTPT,End Reference Time Point,Char,10
+mh,STUDYID,Study Identifier,Char,12
+mh,DOMAIN,Domain Abbreviation,Char,2
+mh,USUBJID,Unique Subject Identifier,Char,8
+mh,MHSEQ,Sequence Number,Num,8
+mh,MHTERM,Reported Term for the Medical History,Char,19
+mh,MHEVDTYP,Medical History Event Date Type,Char,13
+mh,MHSTDTC,Start Date/Time of Medical History Event,Char,10
+mh,MHSTDY,Study Day of Start of Observation,Num,8
+mh,MHENDTC,End Date/Time of Medical History Event,Char,50
+mh,MHENDY,Study Day of End of Observation,Num,8
+mh,MHENRTPT,End Relative to Reference Time Point,Char,50
+mh,MHENTPT,End Reference Time Point,Char,50

Published/CORE-000106/positive/01/data/cm.csv

@@ -8,4 +8,4 @@ CDISCPILOT01,CM,CDISC007,4,BENADRYL,PROPHYLAXIS OR NON-THERAPEUTIC USE,75,mg,,OR
 CDISCPILOT01,CM,CDISC007,5,PREDNISONE,PROPHYLAXIS OR NON-THERAPEUTIC USE,20,mg,,ORAL,SCREENING,2013-02-18,2013-05-10,45,126,,
 CDISCPILOT01,CM,CDISC007,6,TEMOVATE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,TOPICAL,SCREENING,2013-02-18,2013-02-20,45,47,,
 CDISCPILOT01,CM,CDISC011,1,MOTRIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,1998-10,2013-06-05,,181,,
-CDISCPILOT01,CM,CDISC011,2,PRINIVIL,PROPHYLAXIS OR NON-THERAPEUTIC USE,10,mg,,ORAL,SCREENING,2011-07-15,2013-06-05,-511,181,,
+CDISCPILOT01,CM,CDISC011,2,PRINIVIL,PROPHYLAXIS OR NON-THERAPEUTIC USE,10,mg,,ORAL,SCREENING,2011-07-15,2013-06-05,-511,181,,

Published/CORE-000106/positive/02/data/mh.csv → Published/CORE-000106/positive/01/data/mh.csv

@@ -7,4 +7,4 @@ CDISCPILOT01,MH,CDISC013,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2011-07-19,-734,,,O
 CDISCPILOT01,MH,CDISC014,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2011-07-25,-618,2011-07-26,-617,,
 CDISCPILOT01,MH,CDISC016,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2011-04-29,-705,2011-04-29,-705,,
 CDISCPILOT01,MH,CDISC017,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2008-08-20,-1858,2008-08-20,-1858,,
-CDISCPILOT01,MH,CDISC018,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-05-03,-959,2010-05-03,-959,,
+CDISCPILOT01,MH,CDISC018,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-05-03,-959,2010-05-03,-959,,

Published/CORE-000106/rule.yml

@@ -50,23 +50,6 @@ Authorities:
               Version: '1'
             Version: '2.0'
         Version: '3.2'
-      - Name: TIG
-        References:
-          - Citations:
-              - Cited Guidance: The description or date and/or time of a time point that acts as
-                  a fixed reference for characterizing the end of an
-                  observation. This is the sponsor-defined reference point
-                  referred to by --ENRTPT
-                Document: SDTM v2.1
-                Item: --ENTPT
-                Section: Section 3.1.5 Timing Variables for All Classes
-            Origin: TIG Conformance Rules
-            Rule Identifier:
-              Id: TIG0324
-              Version: '1'
-            Version: '1.0'
-        Substandard: SDTM
-        Version: '1.0'
 Check:
   all:
     - name: --ENTPT
@@ -77,10 +60,10 @@ Core:
   Id: CORE-000106
   Status: Published
   Version: '1'
-Description: Raise an error when --ENTPT is completed and --ENRTPT is not completed.
+Description: Raise an error when --ENTPT is populated and --ENRTPT is not populated.
 Executability: Fully Executable
 Outcome:
-  Message: --ENTPT is completed, but --ENRTPT is not completed.
+  Message: --ENTPT is populated, but --ENRTPT is not populated.
   Output Variables:
     - --ENRTPT
     - --ENTPT
@@ -92,5 +75,4 @@ Scope:
   Domains:
     Include:
       - ALL
-  Use Case: INDH, PROD
-Sensitivity: Record
+Sensitivity: Record