From ce85938def2d4fbbbee208901c9328cdb97565d3 Mon Sep 17 00:00:00 2001 From: pendingintent <3921919+pendingintent@users.noreply.github.com> Date: Thu, 13 Aug 2026 11:33:04 -0400 Subject: [PATCH] Changed Sensitivity to Record from Dataset so all records failing validation are reported. --- Published/CORE-000212/rule.yml | 164 ++++++++++++++++----------------- 1 file changed, 78 insertions(+), 86 deletions(-) diff --git a/Published/CORE-000212/rule.yml b/Published/CORE-000212/rule.yml index 202efdf9e..a8031b7ea 100644 --- a/Published/CORE-000212/rule.yml +++ b/Published/CORE-000212/rule.yml @@ -2,104 +2,96 @@ # Condition: Subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' # Rule: DSSCAT must be present Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either - disposition of study participation or of a study - treatment. It describes whether a subject completed study - participation or a study treatment, and if not, the reason - they did not complete it. Dispositions may be described for - each Epoch (e.g., screening, initial treatment, washout, - cross-over treatment, follow-up) or for the study as a whole. - If disposition events for both study participation and study - treatment(s) are to be represented, then DSSCAT provides this - distinction. The value of DSSCAT is based on the sponsor's - controlled terminology, however for records with DSCAT = - "DISPOSITION EVENT", DSSCAT = "STUDY PARTICIPATION" is used to - represent disposition of study participation. DSSCAT = "STUDY - TREATMENT" can be used as a generic identifier when a study - has only a single treatment. If a study has multiple - treatments, then DSSCAT should name the individual treatment. - Document: IG v3.4 - Item: DS – Assumption 2b - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0535 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If separate disposition events for both study participation and - study treatment(s) are to be represented, then DSSCAT provides - this distinction. - Document: IG v3.3 - Item: Assumption 2.b - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0535 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either - disposition of study participation or of a product exposure. - It describes whether a subject completed study participation - or a product exposure and, if not, the reason they did not - complete it. Dispositions may be described for each epoch - (e.g., screening, initial exposure, washout, cross-over, - follow-up) or for the study as a whole. If disposition events - for both study participation and product exposure(s) are to be - represented, then DSSCAT provides this distinction. - Document: TIG 1.0 - Item: Assumption 2b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0628 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of + study participation or of a study treatment. It describes whether a subject completed + study participation or a study treatment, and if not, the reason they did not complete it. + Dispositions may be described for each Epoch (e.g., screening, initial treatment, washout, + cross-over treatment, follow-up) or for the study as a whole. If disposition events for + both study participation and study treatment(s) are to be represented, then DSSCAT + provides this distinction. The value of DSSCAT is based on the sponsor's controlled + terminology, however for records with DSCAT = "DISPOSITION EVENT", DSSCAT = "STUDY + PARTICIPATION" is used to represent disposition of study participation. DSSCAT = "STUDY + TREATMENT" can be used as a generic identifier when a study has only a single treatment. + If a study has multiple treatments, then DSSCAT should name the individual treatment. + Document: IG v3.4 + Item: DS – Assumption 2b + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0535 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If separate disposition events for both study participation and study + treatment(s) are to be represented, then DSSCAT provides this distinction. + Document: IG v3.3 + Item: Assumption 2.b + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0535 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of + study participation or of a product exposure. It describes whether a subject completed + study participation or a product exposure and, if not, the reason they did not complete + it. Dispositions may be described for each epoch (e.g., screening, initial exposure, + washout, cross-over, follow-up) or for the study as a whole. If disposition events for + both study participation and product exposure(s) are to be represented, then DSSCAT + provides this distinction. + Document: TIG 1.0 + Item: Assumption 2b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0628 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DSCAT - operator: is_not_unique_set - value: - - USUBJID - - EPOCH - - name: DSCAT - operator: equal_to - value: DISPOSITION EVENT - - name: DSSCAT - operator: not_exists + - name: DSCAT + operator: is_not_unique_set + value: + - USUBJID + - EPOCH + - name: DSCAT + operator: equal_to + value: DISPOSITION EVENT + - name: DSSCAT + operator: not_exists Core: Id: CORE-000212 Status: Published - Version: '1' -Description: When subject has more than one record per Epoch with DSCAT = - DISPOSITION EVENT, DSSCAT must be present. + Version: "1" +Description: When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT + must be present. Executability: Fully Executable Outcome: - Message: DSSCAT is not present when subject has more than one record per Epoch - with DSCAT = 'DISPOSITION EVENT'. + Message: DSSCAT is not present when subject has more than one record per Epoch with DSCAT = + 'DISPOSITION EVENT'. Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH -Sensitivity: Dataset +Sensitivity: Record