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© CDISC 2014 SDS ELT Rules Team Update Stetson Line 08 Dec
© CDISC 2014 SDS ELT Nov Discussion Decisions from last meeting SDTM 1.4 / SDTMIG 3.2 Rules Publication Supplement (Excel) Target Date by EOQ Rules Development Guide Target Date for Internal Review by Jan 2015 Independent of rules publication SDTM 1.5 / SDTMIG 3.3 Rules Target Date – Summer
© CDISC 2014 FDA SDTM Rules vs. SDS SDTM Rules FDA published 315 rules 11/18 Based on OpenCDISC Validator 1.x with updates New TS domain rules CT rules simplification Deprecated concept of ‘Notice’ type rules Versioned for SDTMIG Approved and maintained by FDA Change Control Board (CCB) Pinnacle 21/OpenCDISC implement these in Validator 2.0 Publisher ID column used to reference FDA Rule ID FDA CCB to evaluate SDS SDTMIG v3.2 Rules (Q1 2015) 4
© CDISC 2014 FDA SDTM Rules vs. SDS SDTM Rules There are gaps/overlaps between FDA/SDS SDTM rules Similar rules with differences in scope Conflicts / differences in interpretation FDA intends regular (semi-annual) updates asynchronous to SDS updates FDA rules parameterized without benefit of parameter datasets Apparent ties to Pinnacle 21 OpenCDISC implementation 5
© CDISC 2014 Sample FDA CT Rules 6 FDA Rule ID MESSAGEDESCRIPTIONDOMAINSSEVERITY (3.1.2 A1) FDAC340Value for not found in ( ) CT codelist ( ) variable values should be populated with terms found in ' ' ( ) CDISC controlled terminology codelist. New values cannot be added into the CDISC CT non-extensible codelist. ALLErrorXX FDAC341Value for not found in ( ) CT codelist ( ) variable values should be populated with terms found in ' ' ( ) CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. ALLWarningXX FDAC343Value for not found in ( ) CT codelist ( ) variable values must be populated with terms found in ' ' ( ) CDISC controlled terminology codelist, when ( ) ' '. New values cannot be added into the CDISC CT non-extensible codelist. ALLErrorXX FDAC344Value for not found in ( ) CT codelist ( ) variable values must be populated with terms found in ' ' ( ) CDISC controlled terminology codelist, when ( ) ' '. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms. ALLWarningXX
© CDISC 2014 SDS Sub-Team Proposed CT Rules Rule IDRuleConditionItem #TextClassDomainVariable ALL_ALL_GEN_05Value in assigned controlled terms or 'MULTIPLE' Assigned non- extensible controlled terms 3.2Conformance with the SDTMIG Domain Models is minimally indicated by following SDTM-specified controlled terminology and format guidelines for variables, when provided ALL GENERAL ALL_ALL_GEN_06Value in assigned controlled terms or in ('MULTIPLE','OTHER') Assigned extensible controlled terms 3.2Conformance with the SDTMIG Domain Models is minimally indicated by following SDTM-specified controlled terminology and format guidelines for variables, when provided ALL GENERAL 7
© CDISC 2014 Questions for SDS ELT Should we be concerned about referencing or with harmonizing SDS rules with FDA rules sets? Option – reference FDA Rule ID as additional metadata? What about rules not approved by FDA CCB or un-implementable? (How will they be viewed by industry?) What is our purview when compliance rules are wrong or misstated? Feedback Would it be advisable for CDISC to have representation on the FDA CCB? 8