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2. © CDISC 2014 SDS ELT Rules Team Update Stetson Line 08 Dec 2014 2

3. © CDISC 2014 SDS ELT Nov 24 2014 Discussion Decisions from last meeting SDTM 1.4 / SDTMIG 3.2 Rules Publication  Supplement (Excel)  Target Date by EOQ1 2015 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 2015 3

4. © 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 3.1.1-3.1.3  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

5. © 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

6. © CDISC 2014 Sample FDA CT Rules 6 FDA Rule ID MESSAGEDESCRIPTIONDOMAINSSEVERITY3.1.13.1.2 3.1.3 (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

7. © 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

8. © 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 edata@fda.hhs.govedata@fda.hhs.gov  Would it be advisable for CDISC to have representation on the FDA CCB? 8