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2. © CDISC 2014 Stetson Line, Team Lead 2 2014 CDISC Intrachange SDTM Rules Sub-team Update

3. © 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

4. © CDISC 2014 Rules Sub-Team Target Milestones Q1 2014  Sub-team Kickoff /Member orientation/ assignments  SDTM IG v3.2 – DM Rules Pilot Q2 2014  SDTM Validation Rules Development Guide  SDTM IG v3.2 – Events Observation Class Rules  SDTM IG v3.2 – Interventions Observation Class Rules Q3 2014  SDTM IG v3.2 – Findings Observation Class Rules  SDTM IG v3.2 – Other Special Purpose Domains Rules Q4 2014  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

5. © CDISC 2014 SDTM Rules Meeting Support 5

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

7. © CDISC 2014 Rules Production DateRulesParking LotDomainsCumlative Hours 21-Apr-145550DM197 9-Jun-14160108AE CE DM DS DV MH MO307.5 21-Jul-14146102AE CE CM DM DS DV EC EX MH MO HO SU PR402 27-Aug-14243121AE CE CM DM DS DV EC EG EX IE IS LB MH MI MO HO SU PC PP PR RS TR TU TIMING553 15-Sep-14236137AE CE CM DM DS DV EC EG EX IE IS LB MB MH MI MS MO HO SU PC PP PR RS TR TU TIMING633.5 7 26 meetings 7+ average attendance

8. © CDISC 2014 Rules Production by Domain 8 250+ Rules 120+ in Draft

9. © 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

10. © 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

11. © 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

12. © 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

13. © 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

14. © 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

15. © CDISC 2014 SHARE Team Draft Rules Model 15

16. © CDISC 2014 Rules Parking Lot Breakdown 16 Issue/ Observation ClassALLEVTFNDINTSPCTotal ERRATA32218 OTHER TEAMS3115 QUESTION FOR ESCALATION31332122 REVISE GUIDANCE1279735 RULE METADATA718 VAR GENERALLY NOT USED491858 Total188115202136

17. © CDISC 2014 Thank You Stetson Line President, clinventive stetson.line@clinventive.com 650-450-3820 17