SDTM Validation Rules Sub-team Kickoff Meeting January 24 th, 2014

© CDISC 2011 Meeting Agenda Introductions Charter and Proposed 2014 Milestones Working Model  Pilot Exercise  Strategy and Key Assumptions  Team Roles and Responsibilities Progress to date Near-term Plan, Calendar of Events AOB 2

© CDISC 2011 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 3

© CDISC 2011 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

© CDISC 2011 Draft 2014 Sub-Team Milestones Q  Sub-team Kickoff /Member orientation/ assignments  SDTM IG v3.2 – DM Validation Rules Draft Q  SDTM IG v3.2 – Events/ Interventions Domains Validation Rules Draft  SDTM Validation Rules IG Draft  Check-in with SDS LT/ Share Team Q  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 Q  SDTM IG v3.2 Validation Rules (submitted for public comment)  SDTM Validation Rule Implementation Guide (submitted for public comment) 5

© CDISC 2011 Proposed Working Model 6

© CDISC 2011 Working Model Pilot Objective is 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 7

© CDISC 2011 Working Model Assumptions Extraction teams working in parallel are likely to identify all potential rules – i.e. it is unlikely that all teams will make the same errors of omission. The Publication team will be another pair of eyes, in effect, when reconciling differences between the extraction teams’ efforts. This team will maintain the draft rules, controlled terminology lists and issue logs in preparation for discussion at the full team meetings and eventual publication. The full team will discuss escalated issues. If issues are not efficiently resolvable they will be documented as unresolved e.g. Parking Lot and escalated to the SDS LT as needed. 8

© CDISC 2011 Working Team Responsibilities (proposed) 9 Rules Extraction Team A  Analyze and extract rules from SDTM IG Rules Extraction Team B  Analyze and extract rules from SDTM IG Rules Publication Team  Analyze and align rules metadata from ID teams  Govern rule classification CT as needed  Document work stream deliverables and guidance Full Team  Resolve issues or agree to escalate  Review and finalize draft deliverables  Status updates/adjustments to working plans as needed.

© CDISC 2011 Progress to Date Charter revised and re-submitted  To be reviewed at 10Feb SDS LT Meeting Rule Sub-team Wiki set-up  Max – Demonstration Extraction Pilot Team  Rules template developed  SDTM 1.4/SDTMIG 3.2 DM Rules partial extraction  Janet/Tom – walkthrough of template and pilot findings so far 10

© CDISC 2011 Near-term Calendar of Events 10Feb – DM Rules Due 21Feb – DM Rules Reconciled/Final Draft 25Feb – 27Feb CDISC INTRAchange  Sub-team update presentation (?)  Opportunity to discuss/refine working model and rules template 14Mar – Full Sub-team Meeting 14Mar – SDTM Validation Rules IG TOC/plan 11Apr – ‘A’ Team Events/Interventions Rules 11Apr – ‘B’ Team Events/Interventions Rules 11

© CDISC 2011 Action Items DM Pilot Volunteers for Working Teams Agenda for INTRAchange Activities Next Full-team Meeting  March 14 th ? Other business? 12