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© CDISC 2014 Stetson Line, Team Lead CDISC Intrachange SDTM Rules Sub-team Update

© CDISC 2014 Mission SDTM Rules Sub-team Identify business rules in guidance and surface these in a clear, consistent and consumable manner –Distinct from data validation rules, focused on compliance, conformance to guidance –Coordinate with SHARE, other teams on rule definition metadata and methods 3

© CDISC 2014 Rules Sub-Team Target Milestones Q  Sub-team Kickoff /Member orientation/ assignments  SDTM IG v3.2 – DM Rules Pilot Q  SDTM Validation Rules Development Guide  SDTM IG v3.2 – Events Observation Class Rules  SDTM IG v3.2 – Interventions Observation Class Rules Q  SDTM IG v3.2 – Findings Observation Class Rules  SDTM IG v3.2 – Other Special Purpose Domains Rules Q  SDTM IG v3.2 – Trial Design Domains Rules  SDTM IG v3.2 Validation Rules (submitted for public comment)  SDTM Validation Rule Implementation Guide (submitted for public comment) 4

© CDISC 2014 SDTM Rules Meeting Support 5

© CDISC 2014 Rule Metadata Elements Rule ID Rule Condition Comments / Questions / Dispositions IG Section IG Item # IG Text Class Domain Variable 6

© CDISC 2014 Rules Production DateRulesParking LotDomainsCumlative Hours 21-Apr DM197 9-Jun AE CE DM DS DV MH MO Jul AE CE CM DM DS DV EC EX MH MO HO SU PR Aug AE CE CM DM DS DV EC EG EX IE IS LB MH MI MO HO SU PC PP PR RS TR TU TIMING Sep AE CE CM DM DS DV EC EG EX IE IS LB MB MH MI MS MO HO SU PC PP PR RS TR TU TIMING meetings 7+ average attendance

© CDISC 2014 Rules Production by Domain Rules 120+ in Draft

© CDISC 2014 Essential ground rules for authoring consistently formed rules  Rule Syntax  Standard Operators /Tokens  Controlled Terminology Document evolution of conventions / best working practices  Currently v1.3 – Mostly refinements in definition of rule scope and hierarchy Rules Development Guide 9

© CDISC 2014 Rules Hierarchy - Rationale All rules are stated uniquely at the highest applicable level of the rule hierarchy possible  Minimizes redundancy and maintenance overhead  Helps drive clarity around core principles and any exceptions to those principles  Aids rule development and review 10

© CDISC 2014 Rules Examples Simple Rule – No Hierarchy 11 Rule IDRuleConditionClassDomainVariable EVT_AE_AESER_01AESER = 'Y'AESCAN = 'Y' or AESCONG = 'Y' or AEDISAB = 'Y' or AEDTH = 'Y' or AESHOSP = 'Y' or AELIFE = 'Y' or AESOD = 'Y' or AESMIE = 'Y' or AECONTRT = 'Y' EVTAEAESER EVT_AE_AESER_02AESER = 'N'AESCAN ^= 'Y' and AESCONG ^= 'Y' and AEDISAB ^= 'Y' and AEDTH ^= 'Y' and AESHOSP ^= 'Y' and AELIFE ^= 'Y' and AESOD ^= 'Y' and AESMIE ^= 'Y' and AECONTRT ^= 'Y' EVTAEAESER

© CDISC 2014 Rules Examples Multiple Domain Rules Rule ID serves as both unique key and pointer to whether additional fields (Class, Domain, Variable) are needed to further refine scope 12 Rule IDRuleConditionClassDomainVariable FND_ALL_--DRVFL_01--DRVFL in ('Y', null) FNDALL--DRVFL FND_ALL_--DRVFL_02--DRVFL = null--STRESC = null or --STAT = 'NOT DONE' FNDALL--DRVFL Rule IDRuleConditionClassDomainVariable INT_MLT_--DOSE_01--DOSE = null--DOSTXT ^= nullINTEX, CM, EC, PR, SU --DOSE INT_MLT_--DOSTXT_01--DOSTXT = null--DOSE ^= nullINTEX, CM, EC, PR, SU --DOSTXT

© CDISC 2014 Rules Examples Multiple Observation Class Rules Notice use of NOT() syntax for excluded domains in last example 13 Rule IDRuleConditionClassDomainVariable MLT_MLT_--OCCUR_01--OCCUR ^= null--PRESP = 'Y' and --STAT ^= 'NOT DONE' EVT,INTMH,CE,HO, CM,EC,PR, SU --OCCUR MLT_MLT_--OCCUR_02--OCCUR = null--PRESP ^= 'Y'EVT,INTMH,CE,HO, CM,EC,PR, SU --OCCUR Rule IDRuleConditionClassDomainVariable MLT_MLT_GEN_01At least one timing variable must exist FND, EVT, INT NOT(IE)GEN

© CDISC 2014 SHARE Team Collaboration SHARE team members on Rules team Ongoing review of SDTM Rules development  Interest in aligning metadata conventions  Preparing for SHARE implementation A. Chow invited to Rules meeting  Discussed feedback on proposed rules  Presented draft CMAP of Rules metadata model  Example conventions – quotes for text values, preceding ‘--’ for domain wildcard in variable naming, categorizing rule types…etc. 14

© CDISC 2014 SHARE Team Draft Rules Model 15

© CDISC 2014 Rules Parking Lot Breakdown 16 Issue/ Observation ClassALLEVTFNDINTSPCTotal ERRATA32218 OTHER TEAMS3115 QUESTION FOR ESCALATION REVISE GUIDANCE RULE METADATA718 VAR GENERALLY NOT USED Total

© CDISC 2014 Thank You Stetson Line President, clinventive