From fe131dfa9ad8ecd562cb34f5ed53aeaf4d825120 Mon Sep 17 00:00:00 2001 From: pendingintent <3921919+pendingintent@users.noreply.github.com> Date: Thu, 13 Aug 2026 15:31:56 -0400 Subject: [PATCH 1/2] Updated output variables, removed redundant negative test 02. --- .../negative/01/results/results(1).csv | 5 + .../negative/01/results/results.csv | 4 +- Published/CORE-000224/negative/02/data/.env | 2 - .../negative/02/data/_datasets.csv | 3 - .../negative/02/data/_variables.csv | 36 ------ Published/CORE-000224/negative/02/data/ae.csv | 10 -- Published/CORE-000224/negative/02/data/dm.csv | 5 - .../negative/02/results/results.csv | 2 - Published/CORE-000224/rule.yml | 122 +++++++++--------- 9 files changed, 66 insertions(+), 123 deletions(-) create mode 100644 Published/CORE-000224/negative/01/results/results(1).csv delete mode 100644 Published/CORE-000224/negative/02/data/.env delete mode 100644 Published/CORE-000224/negative/02/data/_datasets.csv delete mode 100644 Published/CORE-000224/negative/02/data/_variables.csv delete mode 100644 Published/CORE-000224/negative/02/data/ae.csv delete mode 100644 Published/CORE-000224/negative/02/data/dm.csv delete mode 100644 Published/CORE-000224/negative/02/results/results.csv diff --git a/Published/CORE-000224/negative/01/results/results(1).csv b/Published/CORE-000224/negative/01/results/results(1).csv new file mode 100644 index 000000000..233eeb9b3 --- /dev/null +++ b/Published/CORE-000224/negative/01/results/results(1).csv @@ -0,0 +1,5 @@ +Dataset,Record,Variable,Value +DM,4,USUBJID,CDISC004 +DM,5,USUBJID,CDISC005 +DM,6,USUBJID,CDISC006 +DM,7,USUBJID,CDISC007 diff --git a/Published/CORE-000224/negative/01/results/results.csv b/Published/CORE-000224/negative/01/results/results.csv index 89796920b..0ede1c8a6 100644 --- a/Published/CORE-000224/negative/01/results/results.csv +++ b/Published/CORE-000224/negative/01/results/results.csv @@ -1,9 +1,9 @@ Dataset,Record,Variable,Value -DM,3,ACTARM, -DM,3,ARMNRS, DM,4,ACTARM, DM,4,ARMNRS, DM,5,ACTARM, DM,5,ARMNRS, DM,6,ACTARM, DM,6,ARMNRS, +DM,7,ACTARM, +DM,7,ARMNRS, diff --git a/Published/CORE-000224/negative/02/data/.env b/Published/CORE-000224/negative/02/data/.env deleted file mode 100644 index 8f9bf60aa..000000000 --- a/Published/CORE-000224/negative/02/data/.env +++ /dev/null @@ -1,2 +0,0 @@ -PRODUCT=SDTMIG -VERSION=3-4 diff --git a/Published/CORE-000224/negative/02/data/_datasets.csv b/Published/CORE-000224/negative/02/data/_datasets.csv deleted file mode 100644 index 5da1cd273..000000000 --- a/Published/CORE-000224/negative/02/data/_datasets.csv +++ /dev/null @@ -1,3 +0,0 @@ -Filename,Label -dm,Demographics -ae,Adverse Events diff --git a/Published/CORE-000224/negative/02/data/_variables.csv b/Published/CORE-000224/negative/02/data/_variables.csv deleted file mode 100644 index cf330b43a..000000000 --- a/Published/CORE-000224/negative/02/data/_variables.csv +++ /dev/null @@ -1,36 +0,0 @@ -dataset,variable,label,type,length -dm,STUDYID,Study Identifier,Char,12 -dm,DOMAIN,Domain Abbreviation,Char,2 -dm,USUBJID,Unique Subject Identifier,Char,8 -dm,SUBJID,Subject Identifier for the Study,Char,4 -dm,RFSTDTC,Subject Reference Start Date/Time,Char,10 -dm,RFENDTC,Subject Reference End Date/Time,Char,10 -dm,RFXSTDTC,Date/Time of First Study Treatment,Char,10 -dm,RFXENDTC,Date/Time of Last Study Treatment,Char,10 -dm,RFICDTC,Date/Time of Informed Consent,Char,10 -dm,RFPENDTC,Date/Time of End of Participation,Char,10 -dm,DTHDTC,Date/Time of Death,Char,10 -dm,DTHFL,Subject Death Flag,Char,1 -dm,SITEID,Study Site Identifier,Char,3 -dm,BRTHDTC,Date/Time of Birth,Char,10 -dm,AGE,Age,Num,8 -dm,AGEU,Age Units,Char,5 -dm,SEX,Sex,Char,1 -dm,RACE,Race,Char,41 -dm,ETHNIC,Ethnicity,Char,22 -dm,ARMCD,Planned Arm Code,Char,8 -dm,ARM,Description of Planned Arm,Char,28 -dm,ACTARMCD,Actual Arm Code,Char,8 -dm,ACTARM,Description of Actual Arm,Char,28 -dm,ARMNRS,Reason Arm and/or Actual Arm is Null,Char,14 -dm,ACTARMUD,Description of Unplanned Actual Arm,Char,200 -dm,COUNTRY,Country,Char,3 -ae,STUDYID,Study Identifier,Char,12 -ae,DOMAIN,Domain Abbreviation,Char,2 -ae,USUBJID,Unique Subject Identifier,Char,8 -ae,AETERM,Reported Term for the Adverse Event,Char,40 -ae,AESER,Serious Event,Char,1 -ae,AEOUT,Outcome of Adverse Event,Char,40 -ae,AESDTH,Results in Death ,Char,1 -ae,AESTDTC,Start Date/Time of Adverse Event,Char,19 -ae,AEENDTC,End Date/Time of Adverse Event,Char,19 diff --git a/Published/CORE-000224/negative/02/data/ae.csv b/Published/CORE-000224/negative/02/data/ae.csv deleted file mode 100644 index 37654cedf..000000000 --- a/Published/CORE-000224/negative/02/data/ae.csv +++ /dev/null @@ -1,10 +0,0 @@ -STUDYID,DOMAIN,USUBJID,AETERM,AESER,AEOUT,AESDTH,AESTDTC,AEENDTC -CDISCPILOT01,AE,CDISC001,SHOULDER PAIN,N,NOT RECOVERED/NOT RESOLVED,,2018-07-08, -CDISCPILOT01,AE,CDISC001,HYPERTENSION,N,RECOVERED/RESOLVED,,2018-07-23,2018-07-23 -CDISCPILOT01,AE,CDISC001,PNEUMONIA,Y,FATAL,Y,2018-08-14,2018-08-22 -CDISCPILOT01,AE,CDISC002,WORSENING OF LEFT CATARACT,N,RECOVERED/RESOLVED,,2018-10-22,2018-10-22 -CDISCPILOT01,AE,CDISC002,FEVER,N,RECOVERED/RESOLVED,,2018-11-02,2018-11-03 -CDISCPILOT01,AE,CDISC002,HEALTH DETERIORATION DUE TO PROGRESSION OF DISEASE,Y,FATAL,Y,2018-11-12,2019-02-04 -CDISCPILOT01,AE,CDISC003,VERTIGO,Y,RECOVERED/RESOLVED,,2018-08-06,2018-11-09 -CDISCPILOT01,AE,CDISC003,HEARING LOSS,Y,RECOVERED/RESOLVED,,2018-09-03,2018-10-09 -CDISCPILOT01,AE,CDISC003,HEART ATTACK,Y,FATAL,Y,2018-12-11,2018-12-11 diff --git a/Published/CORE-000224/negative/02/data/dm.csv b/Published/CORE-000224/negative/02/data/dm.csv deleted file mode 100644 index 248908958..000000000 --- a/Published/CORE-000224/negative/02/data/dm.csv +++ /dev/null @@ -1,5 +0,0 @@ -STUDYID,DOMAIN,USUBJID,SUBJID,RFSTDTC,RFENDTC,RFXSTDTC,RFXENDTC,RFICDTC,RFPENDTC,DTHDTC,DTHFL,SITEID,BRTHDTC,AGE,AGEU,SEX,RACE,ETHNIC,ARMCD,ARM,ACTARMCD,ACTARM,ARMNRS,ACTARMUD,COUNTRY -CDISCPILOT01,DM,CDISC001,1115,2018-05-17T09:35,2018-08-03,2018-05-17T09:35,2018-08-03,2018-04-26,2018-08-22,2018-08-22,,701,1947-07-24 00:00:00,70,YEARS,M,WHITE,NOT HISPANIC OR LATINO,A,Drug A,A,Drug A,,,AUS -CDISCPILOT01,DM,CDISC002,1211,2018-05-24T12:00,2018-11-06,2018-05-24T12:00,2018-11-06,2018-05-07,2019-02-04,2019-02-04,Y,701,1905-05-08 00:00:00,78,YEARS,M,WHITE,NOT HISPANIC OR LATINO,P,Placebo,P,Placebo,,,AUS -CDISCPILOT01,DM,CDISC003,1302,2006-01-16,2006-03-19,2006-01-16,2006-03-19,2006-01-02,2006-03-19,2018-12-11,Y,701,1944-06-16 00:00:00,74,YEARS,M,WHITE,NOT HISPANIC OR LATINO,B,Drug B,B,Drug B,,,CZE -CDISCPILOT01,DM,CDISC004,1402,2018-07-16T09:15,2018-11-06T14:00,2018-07-16T09:15,2018-11-06T14:00,2018-06-27,2018-12-11,,,701,1905-04-16 00:00:00,68,YEARS,F,WHITE,HISPANIC OR LATINO,B,Drug B,B,Drug B,,,CAN diff --git a/Published/CORE-000224/negative/02/results/results.csv b/Published/CORE-000224/negative/02/results/results.csv deleted file mode 100644 index 41b8b7446..000000000 --- a/Published/CORE-000224/negative/02/results/results.csv +++ /dev/null @@ -1,2 +0,0 @@ -Dataset,Record,Variable,Value -DM,1,DTHFL, diff --git a/Published/CORE-000224/rule.yml b/Published/CORE-000224/rule.yml index 68c6960bb..1beb41dbb 100644 --- a/Published/CORE-000224/rule.yml +++ b/Published/CORE-000224/rule.yml @@ -2,84 +2,80 @@ # Condition: ACTARM = null # Rule: ARMNRS^=null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage 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, ACTARM is null and ARMNRS is - populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0515 - 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: CG0515 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - 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: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0610 - 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 multi-stage 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, ACTARM is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0515 + 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: CG0515 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + 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: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0610 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARM - operator: empty - - name: ARMNRS - operator: empty + - name: ACTARM + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000224 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ACTARM is empty and ARMNRS is not completed. Executability: Fully Executable Outcome: Message: ACTARM is empty, but ARMNRS is not completed. Output Variables: - - ACTARM - - ARMNRS + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record From 597fc796bbedddb06dcafcc82aaa76872799f025 Mon Sep 17 00:00:00 2001 From: pendingintent <3921919+pendingintent@users.noreply.github.com> Date: Thu, 13 Aug 2026 15:34:52 -0400 Subject: [PATCH 2/2] Updated results.csv file --- .../CORE-000224/negative/01/results/results(1).csv | 5 ----- .../CORE-000224/negative/01/results/results.csv | 12 ++++-------- 2 files changed, 4 insertions(+), 13 deletions(-) delete mode 100644 Published/CORE-000224/negative/01/results/results(1).csv diff --git a/Published/CORE-000224/negative/01/results/results(1).csv b/Published/CORE-000224/negative/01/results/results(1).csv deleted file mode 100644 index 233eeb9b3..000000000 --- a/Published/CORE-000224/negative/01/results/results(1).csv +++ /dev/null @@ -1,5 +0,0 @@ -Dataset,Record,Variable,Value -DM,4,USUBJID,CDISC004 -DM,5,USUBJID,CDISC005 -DM,6,USUBJID,CDISC006 -DM,7,USUBJID,CDISC007 diff --git a/Published/CORE-000224/negative/01/results/results.csv b/Published/CORE-000224/negative/01/results/results.csv index 0ede1c8a6..233eeb9b3 100644 --- a/Published/CORE-000224/negative/01/results/results.csv +++ b/Published/CORE-000224/negative/01/results/results.csv @@ -1,9 +1,5 @@ Dataset,Record,Variable,Value -DM,4,ACTARM, -DM,4,ARMNRS, -DM,5,ACTARM, -DM,5,ARMNRS, -DM,6,ACTARM, -DM,6,ARMNRS, -DM,7,ACTARM, -DM,7,ARMNRS, +DM,4,USUBJID,CDISC004 +DM,5,USUBJID,CDISC005 +DM,6,USUBJID,CDISC006 +DM,7,USUBJID,CDISC007