WG4: Standards Implementation Issues with CDISC Data Models

1. WG4: Standards Implementation Issues with CDISC Data Models

2. Meeting Purpose and Outcomes Purpose Provide WG4 volunteers with an overview of WG4 and prepare volunteers for the PhUSE/FDA CSS Outcomes • Volunteers understand the purpose and scope of WG4 • Volunteers are able to locate WG4 content • CSS attendees will be prepared to actively participate

3. Agenda • Introductions • Charter • Identified Issues, WG4 PhUSE Wiki • WG4 CSS Conference Sessions • Conference Pre-Work • Q&A

4. WG4 Leadership Helena Sviglin, CDER Steve Wilson, CDER John Brega, PharmaStat Joanna Koft, Biogen Idec Liz Leahy, Roche Scott Bahlavooni, Genentech

5. WG4 Charter Mission Identify specific issues implementing the CDISC data standards on individual study elements, prioritize these issues, make recommendations for changes or best practices that will be shared across the FDA and Industry. Scope Issues related to industry implementation of SDTM and FDA review of SDTM submissions. Issues with other CDISC models (e.g. ADaM, SEND, etc.) are initially out of scope.

6. WG4 Charter Cont. Goals and Objectives • Identify and prioritize a list of common issues • Identify, prioritize, and track additional issues • Develop use cases for highest priority issues • Create white paper and/or best practice documents • Co-authored with the FDA • Not regulatory guidance documents • Define meeting logistics for the next year

7. Identified Issues/WG4 PhUSE Wiki • WG4 Leadership identified and prioritized a set of issues • Identified based on CDER Reviewer feedback, CDER Common Data Standards Issues, and sponsor implementation experience • Additional issues will be gathered from WG4 volunteers • Issues category examples • Model: Issues directly related to CDISC models or CT • Data Guide (aka “Reviewer’s Guide”): Issues related to sponsor documentation of data standards in a submission • Review: Issues related to CDER review • Industry Implementation: Issues related to industry implementation of CDISC data models • Issues have been posted to the PhUSE Wiki

8. WG4 CSS Sessions • Collection of additional challenges and issues from attendees • Attendees will be split into two groups before Breakout Session • Breakout Sessions will address the same two issues • CDG-010: Sponsors often fail to adequately document mapping decisions, sponsor-defined domains, and sponsor-extensions to CDISC CT in a Data Guide. A standardized Data Guide would help to address this documentation gap. • REV-030: Sponsors often include unnecessary operational content that should not be submitted (e.g. subject initials) in sponsor-defined domains, core domain variables, supplemental qualifiers or FA.

9. WG4 CSS Sessions Cont. • Breakout Session outcomes • List of use cases • Rough outline that will be developed into a white paper or best practice document • WG4 attendees will reconvene and discuss Breakout Session • WG4 Leadership will coalesce outcomes to move forward after CSS

10. Conference Pre-work • Review issues on the PhUSE Wiki • Identify your top three standards implementation issues • Your issues may differ from those identified by WG4 Leadership • Please indicate if your issue is similar or related to the identified issues • Your issues will be discussed and logged; please bring them to the CSS • Send examples of your Data Guide or Reviewer’s Guide to WG4 Leadership • Examples should conform to your company’s confidentiality requirements • Content will not be shared outside of this WG

11. Meeting Purpose and Outcomes Purpose Provide WG4 volunteers with an overview of WG4 and prepare volunteers for the PhUSE/FDA CSS Outcomes • Volunteers understand the purpose and scope of WG4 • Volunteers are able to locate WG4 content • Volunteers are able to attend CSS prepared to actively participate

12. Questions