diff --git a/Published/CORE-000106/negative/01/data/.env b/Published/CORE-000106/negative/01/data/.env index 8f9bf60aa..929573120 100644 --- a/Published/CORE-000106/negative/01/data/.env +++ b/Published/CORE-000106/negative/01/data/.env @@ -1,2 +1,2 @@ PRODUCT=SDTMIG -VERSION=3-4 +VERSION=3-4 \ No newline at end of file diff --git a/Published/CORE-000106/negative/01/data/_datasets.csv b/Published/CORE-000106/negative/01/data/_datasets.csv index 396eaafcb..0c33e49be 100644 --- a/Published/CORE-000106/negative/01/data/_datasets.csv +++ b/Published/CORE-000106/negative/01/data/_datasets.csv @@ -1,2 +1,3 @@ Filename,Label cm,Concomitant/Prior Medications +mh,Medical History \ No newline at end of file diff --git a/Published/CORE-000106/negative/01/data/_variables.csv b/Published/CORE-000106/negative/01/data/_variables.csv index 47c15b9ac..a1aa0376d 100644 --- a/Published/CORE-000106/negative/01/data/_variables.csv +++ b/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 \ No newline at end of file diff --git a/Published/CORE-000106/negative/01/data/cm.csv b/Published/CORE-000106/negative/01/data/cm.csv index c16fe7791..b5e036019 100644 --- a/Published/CORE-000106/negative/01/data/cm.csv +++ b/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 \ No newline at end of file diff --git a/Published/CORE-000106/negative/02/data/mh.csv b/Published/CORE-000106/negative/01/data/mh.csv similarity index 95% rename from Published/CORE-000106/negative/02/data/mh.csv rename to Published/CORE-000106/negative/01/data/mh.csv index 8bde426ca..a61f3d366 100644 --- a/Published/CORE-000106/negative/02/data/mh.csv +++ b/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 \ No newline at end of file diff --git a/Published/CORE-000106/negative/01/results/results.csv b/Published/CORE-000106/negative/01/results/results.csv index 22d058382..fba4fdf87 100644 --- a/Published/CORE-000106/negative/01/results/results.csv +++ b/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 diff --git a/Published/CORE-000106/negative/02/data/.env b/Published/CORE-000106/negative/02/data/.env deleted file mode 100644 index 8f9bf60aa..000000000 --- a/Published/CORE-000106/negative/02/data/.env +++ /dev/null @@ -1,2 +0,0 @@ -PRODUCT=SDTMIG -VERSION=3-4 diff --git a/Published/CORE-000106/negative/02/data/_datasets.csv b/Published/CORE-000106/negative/02/data/_datasets.csv deleted file mode 100644 index 6f9ed280a..000000000 --- a/Published/CORE-000106/negative/02/data/_datasets.csv +++ /dev/null @@ -1,2 +0,0 @@ -Filename,Label -mh,Medical History diff --git a/Published/CORE-000106/negative/02/data/_variables.csv b/Published/CORE-000106/negative/02/data/_variables.csv deleted file mode 100644 index 367bed983..000000000 --- a/Published/CORE-000106/negative/02/data/_variables.csv +++ /dev/null @@ -1,13 +0,0 @@ -dataset,variable,label,type,length -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 diff --git a/Published/CORE-000106/negative/02/results/results.csv b/Published/CORE-000106/negative/02/results/results.csv deleted file mode 100644 index 4e654f26c..000000000 --- a/Published/CORE-000106/negative/02/results/results.csv +++ /dev/null @@ -1,17 +0,0 @@ -Dataset,Record,Variable,Value -MH.csv,0,MHENRTPT, -MH.csv,0,MHENTPT,2021-05-01 -MH.csv,1,MHENRTPT, -MH.csv,1,MHENTPT,2021-02-15 -MH.csv,2,MHENRTPT, -MH.csv,2,MHENTPT,2015-05-09 -MH.csv,3,MHENRTPT, -MH.csv,3,MHENTPT,2011-06-11 -MH.csv,4,MHENRTPT, -MH.csv,4,MHENTPT,2000-06-11 -MH.csv,5,MHENRTPT, -MH.csv,5,MHENTPT,2021-05-01 -MH.csv,6,MHENRTPT, -MH.csv,6,MHENTPT,2021-05-02 -MH.csv,7,MHENRTPT, -MH.csv,7,MHENTPT,2021-11-23 diff --git a/Published/CORE-000106/positive/01/data/.env b/Published/CORE-000106/positive/01/data/.env index 8f9bf60aa..929573120 100644 --- a/Published/CORE-000106/positive/01/data/.env +++ b/Published/CORE-000106/positive/01/data/.env @@ -1,2 +1,2 @@ PRODUCT=SDTMIG -VERSION=3-4 +VERSION=3-4 \ No newline at end of file diff --git a/Published/CORE-000106/positive/01/data/_datasets.csv b/Published/CORE-000106/positive/01/data/_datasets.csv index 396eaafcb..0c33e49be 100644 --- a/Published/CORE-000106/positive/01/data/_datasets.csv +++ b/Published/CORE-000106/positive/01/data/_datasets.csv @@ -1,2 +1,3 @@ Filename,Label cm,Concomitant/Prior Medications +mh,Medical History \ No newline at end of file diff --git a/Published/CORE-000106/positive/01/data/_variables.csv b/Published/CORE-000106/positive/01/data/_variables.csv index 47c15b9ac..a1aa0376d 100644 --- a/Published/CORE-000106/positive/01/data/_variables.csv +++ b/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 \ No newline at end of file diff --git a/Published/CORE-000106/positive/01/data/cm.csv b/Published/CORE-000106/positive/01/data/cm.csv index 8d3dfcf37..47d01bb1a 100644 --- a/Published/CORE-000106/positive/01/data/cm.csv +++ b/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,, \ No newline at end of file diff --git a/Published/CORE-000106/positive/02/data/mh.csv b/Published/CORE-000106/positive/01/data/mh.csv similarity index 96% rename from Published/CORE-000106/positive/02/data/mh.csv rename to Published/CORE-000106/positive/01/data/mh.csv index 3f660ba78..af6b42722 100644 --- a/Published/CORE-000106/positive/02/data/mh.csv +++ b/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,, \ No newline at end of file diff --git a/Published/CORE-000106/positive/02/data/.env b/Published/CORE-000106/positive/02/data/.env deleted file mode 100644 index 8f9bf60aa..000000000 --- a/Published/CORE-000106/positive/02/data/.env +++ /dev/null @@ -1,2 +0,0 @@ -PRODUCT=SDTMIG -VERSION=3-4 diff --git a/Published/CORE-000106/positive/02/data/_datasets.csv b/Published/CORE-000106/positive/02/data/_datasets.csv deleted file mode 100644 index 6f9ed280a..000000000 --- a/Published/CORE-000106/positive/02/data/_datasets.csv +++ /dev/null @@ -1,2 +0,0 @@ -Filename,Label -mh,Medical History diff --git a/Published/CORE-000106/positive/02/data/_variables.csv b/Published/CORE-000106/positive/02/data/_variables.csv deleted file mode 100644 index 367bed983..000000000 --- a/Published/CORE-000106/positive/02/data/_variables.csv +++ /dev/null @@ -1,13 +0,0 @@ -dataset,variable,label,type,length -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 diff --git a/Published/CORE-000106/positive/02/results/results.csv b/Published/CORE-000106/positive/02/results/results.csv deleted file mode 100644 index a13018c5f..000000000 --- a/Published/CORE-000106/positive/02/results/results.csv +++ /dev/null @@ -1 +0,0 @@ -Dataset,Record,Variable,Value diff --git a/Published/CORE-000106/rule.yml b/Published/CORE-000106/rule.yml index a81a28f25..6a553c259 100644 --- a/Published/CORE-000106/rule.yml +++ b/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 \ No newline at end of file