diff --git a/Published/CORE-000248/rule.yml b/Published/CORE-000248/rule.yml index 5b7ca3734..6a6857147 100644 --- a/Published/CORE-000248/rule.yml +++ b/Published/CORE-000248/rule.yml @@ -2,316 +2,299 @@ # Condition: --TPTREF = null # Rule: --RFTDTC = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a - fixed reference for a series of planned time points, - represented in a standardized character format. The fixed - reference point is in --TPTREF - Document: Model v2.0 - Item: --RFTDTC - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF - Document: Model v1.7 - Item: --RFTDTC - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF - in ISO 8601 character format. - Document: Model v1.4 - Item: Table 2.2.5, --RFTDTC - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be - provided. - Document: IG v3.0 - Section: 4.4.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: "When instances of an activity are scheduled at planned time - intervals relative to a fixed reference point (e.g., an - exposure), the following timing variables will be used - --TPTREF Represents a description of the fixed reference point - from which the planned observation will be made. --RFTDTC - Represents the actual date/time of the value of --TPTREF" - Document: TIG v1.0 - Item: Timing Relative to Reference Points, Table Num 3 - Section: 2.8.7.6 Representing References and Relative Timing - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0265 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a - fixed reference for a series of planned time points, - represented in a standardized character format. The fixed - reference point is in --TPTREF. - Document: SDTM v2.1 - Item: --RFTDTC - Section: 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0308 - Version: "1" - Version: "1.0" - Substandard: SDTM - Version: "1.0" - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF + Document: Model v2.0 + Item: --RFTDTC + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF + Document: Model v1.7 + Item: --RFTDTC + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 + character format. + Document: Model v1.4 + Item: Table 2.2.5, --RFTDTC + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be provided. + Document: IG v3.0 + Section: 4.4.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: "When instances of an activity are scheduled at planned time intervals relative + to a fixed reference point (e.g., an exposure), the following timing variables will be used + --TPTREF Represents a description of the fixed reference point from which the planned observation + will be made. --RFTDTC Represents the actual date/time of the value of --TPTREF" + Document: TIG v1.0 + Item: Timing Relative to Reference Points, Table Num 3 + Section: 2.8.7.6 Representing References and Relative Timing + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0265 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF. + Document: SDTM v2.1 + Item: --RFTDTC + Section: 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0308 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: + - any: + - name: --TPTREF + operator: not_exists - name: --TPTREF operator: empty - - name: --RFTDTC - operator: exists - - name: --RFTDTC - operator: non_empty + - name: --RFTDTC + operator: exists + - name: --RFTDTC + operator: non_empty Core: Id: CORE-000248 Status: Published - Version: '1' -Description: Time point reference (--TPTREF) should be populated when reference - time point (--RFTDTC) is populated. + Version: "1" +Description: Time point reference (--TPTREF) should be populated when reference time point + (--RFTDTC) is populated. Executability: Fully Executable Outcome: Message: --TPTREF value is missing when --RFTDTC is populated. @@ -319,9 +302,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record