1. SDTM Validation Rules Sub-team CDISC INTRAchange Feb 26 th, 2014

2. © CDISC 2014 SDTM Rules Sub-Team Introducing the Team Proposed 2014 Deliverables Progress so far… INTRAChange Topics  Rules Sub-Team SOW – ‘Focus and Simplify’  Issues/ Questions 2

3. © CDISC 2014 Sub-Team Membership (so far) Stetson Line – Amgen Tom Guinter – Independent Janet Reich – Amgen Max Kanevsky – Pinnacle21 Sergiy Sirichenko – Pinnacle21 Scott Bahlavooni – Biogen IDEC Anne Russotto – Celgene Carlos Radovsky – etera solutions Bess LeRoy – Cpath.org Gary Walker – Quintiles Dan DiPremio – BioMarin Sue Sullivan – d-Wise Technologies 3

4. © CDISC 2014 Proposed Sub-Team Goals Comprehensive SDTM IG v3.2 Validation Rules SDTM Validation Rule Implementation Guide (Documents rule metadata and usage to enable SDS sub- teams to publish standard validation rules as part of future IGs). 4

5. © CDISC 2014 Draft 2014 Sub-Team Milestones Q1 2014  Sub-team Kickoff /Member orientation/ assignments  SDTM IG v3.2 – DM Validation Rules Draft Q2 2014  SDTM IG v3.2 – Events/ Interventions Domains Validation Rules Draft  SDTM Validation Rules IG Draft  Check-in with SDS LT/ Share Team Q3 2014  SDTM IG v3.2 – Findings Domains Validation Rules Draft  SDTM IG v3.2 – Findings About Domains Validation Rules Draft  SDTM IG v3.2 – Other Special Purpose Domains Validation Rules Draft Q4 2014  SDTM IG v3.2 Validation Rules (submitted for public comment)  SDTM Validation Rule Implementation Guide (submitted for public comment) 5

6. © CDISC 2014 Progress to Date Charter Approved Rules Sub-team Wiki set-up Extraction DM Pilot  Rules template developed  SDTM 1.4/SDTMIG 3.2 DM Rules extracted Analysis ongoing 6

7. © CDISC 2014 SDTM Validation Rules Wiki Space 7

8. © CDISC 2014 Rules Template – ‘Metadata Model’ 8

9. © CDISC 2014 Working Model Pilot – DM Rules Objective: to get many different perspectives and experiences in order to refine the approach for the remaining domains/ observation classes.  Pilot Exercise – DM Domain Using draft rules template extract all text that may indicate DM rules from SDTM 1.4/SDTMIG 3.2 Record all potential interpretations Reconciliation team to harmonize and consolidate Full team review of rule metadata and potential interpretations 9

10. © CDISC 2014 Rules Team Scope Extract all business logic and data conformance rules? What about data quality?  Is the output expected to be comprehensive or only what is not captured e.g. DDT attributes, structural SDTM compliance? Inferred data quality? Rules metadata model:  English-like, not concerned with rigorous application of CT or rule syntax? More principle than law. VS.  Consistent syntax and CT, but perhaps too granular, lacking readability. More law than principle. Implementable in Share? Do we know? 10

11. © CDISC 2014 Rules Questions Screen failures - expected to be included or excluded?  Data for screen failure subjects, if submitted, should be included in the Demographics dataset, with ARMCD = “SCRNFAIL" and ARM = “Screen Failure”  Conditional rule? Add parameter to TS? ACTARM, ACTARMCD – implementation in complex trials are problematic, and are values expected to match TRTxxA (ADaM)? Population flags – expected?  Conditional rule? Add parameter to TS? 11

12. © CDISC 2014 Rules Questions Professional patients, patients shopping sites/arms – multiple DM records? What is the rule? Additional guidance needed.  Multiple records / different SUBJIDs  VS.  One record per patient/USUBJID Map secondary to SUPPDM Where can a variable be used? Class level rules? 12

13. © CDISC 2014 Rules Questions Managing Duplicate Rules Rules class heirarchies – e.g.  If Core Variable Status = Req then Variable must exist  Vs.  USUBJID must exist, ARM must exist, etc. Overall Guidance Heirarchy  SHARE (Future) SDTM –Class »Domain Can children refine / restrict parent rules? 13