1 2014 CDISC Intrachange SDTM Rules Sub-team Update

1 2014 CDISC Intrachange SDTM Rules Sub-team Update

1 2014 CDISC Intrachange SDTM Rules Sub-team Update Stetson Line, Team Lead CDISC 2014 2 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 CDISC 2014 3 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) CDISC 2014 4 SDTM Rules Meeting Support CDISC 2014 5 Rule Metadata Elements

Rule ID Rule Condition Comments / Questions / Dispositions IG Section IG Item # IG Text Class Domain Variable CDISC 2014 6 700 Rules Production 600 500 400

Parking Lot Rules Cumlative Hours 300 200 26 meetings 7+ average attendance 100 0 21-Apr-14 9-Jun-14 Date Rules 21-Apr-14 9-Jun-14 21-Jul-14 27-Aug-14 15-Sep-14 CDISC 2014

21-Jul-14 27-Aug-14 Parking Lot Domains 55 160 146 243 236 50 DM 108 AE CE DM DS DV MH MO 102 AE CE CM DM DS DV EC EX MH MO HO SU PR 121 AE CE CM DM DS DV EC EG EX IE IS LB MH MI MO HO SU PC PP PR RS TR TU TIMING 137 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 15-Sep-14 Cumlative Hours 197 307.5 402 553 633.5 7 Rules Production by Domain AE

CE CM CO DM DS DV EX/EC FA IE LB MB/MS/MI MH Multiple Parking Lot PC_PP PE SE SS SV TA Timing TU/TR/RS TV Sum of Draft Rules Sum of Rules 250+ Rules 120+ in Draft

0 CDISC 2014 20 40 60 80 100 120 8 Rules Development Guide 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

CDISC 2014 9 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 CDISC 2014 10 Rules Examples Simple Rule No Hierarchy Rule ID Rule EVT_AE_AESER_01 AESER = 'Y' EVT_AE_AESER_02 AESER = 'N' CDISC 2014 Condition Class AESCAN = 'Y' or AESCONG = 'Y' or

EVT AEDISAB = 'Y' or AEDTH = 'Y' or AESHOSP = 'Y' or AELIFE = 'Y' or AESOD = 'Y' or AESMIE = 'Y' or AECONTRT = 'Y' AESCAN ^= 'Y' and AESCONG ^= 'Y' and EVT AEDISAB ^= 'Y' and AEDTH ^= 'Y' and AESHOSP ^= 'Y' and AELIFE ^= 'Y' and AESOD ^= 'Y' and AESMIE ^= 'Y' and AECONTRT ^= 'Y' Domain Variable AE AESER AE AESER 11 Rules Examples Multiple Domain Rules Rule ID Rule Condition FND_ALL_--DRVFL_01 --DRVFL in ('Y', null) Class FND

Domain ALL Variable --DRVFL FND_ALL_--DRVFL_02 --DRVFL = null --STRESC = null or --STAT = 'NOT DONE' FND ALL --DRVFL Rule ID INT_MLT_--DOSE_01 Condition --DOSTXT ^= null Class INT Variable --DOSE

--DOSE ^= null INT Domain EX, CM, EC, PR, SU EX, CM, EC, PR, SU Rule --DOSE = null INT_MLT_--DOSTXT_01 --DOSTXT = null --DOSTXT Rule ID serves as both unique key and pointer to whether additional fields (Class, Domain, Variable) are needed to further refine scope CDISC 2014 12 Rules Examples Multiple Observation Class Rules Rule ID Rule

MLT_MLT_--OCCUR_01 --OCCUR ^= null Condition --PRESP = 'Y' and --STAT ^= 'NOT DONE' Class EVT,INT Domain Variable MH,CE,HO, --OCCUR CM,EC,PR, SU MLT_MLT_--OCCUR_02 --OCCUR = null --PRESP ^= 'Y' EVT,INT MH,CE,HO, --OCCUR CM,EC,PR, SU Rule ID MLT_MLT_GEN_01 Condition

Class FND, EVT, INT Domain NOT(IE) Rule At least one timing variable must exist Variable GEN Notice use of NOT() syntax for excluded domains in last example CDISC 2014 13 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 typesetc. CDISC 2014 14 SHARE Team Draft Rules Model CDISC 2014 15 Rules Parking Lot Breakdown Issue/ Observation Class ERRATA ALL EVT 3 OTHER TEAMS QUESTION FOR ESCALATION REVISE GUIDANCE 2 SPC

Total 1 8 1 1 5 1 22 3 13 3 2 12 7 9


1 8 81 15 20 2 136 16 Thank You Stetson Line President, clinventive [email protected] 650-450-3820 CDISC 2014 17

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