WG4: Standards Implementation Issues with CDISC Data Models Data Guide Subteam

1. WG4: Standards Implementation Issues with CDISC Data ModelsData Guide Subteam Summary of Review of Proposed Templates and Next Steps July 23, 2012

2. Agenda • Recap of Data Guide project plan • Summary of review of proposed templates • Next steps • Q&A

3. Data Guide Sub-team Sub-team Co-leads: • Scott Bahlavooni, Genentech • Joanna Koft, Biogen Idec • Gail Stoner, J&J (also CDISC liaison) • Helena Sviglin, CDER FDA • Douglas Warfield, CDER FDA • Amy Malla, CBER FDA

4. Data Guide Project Plan (1) Project Plan: • Review existing Data Guide examples and begin discussion around content • Identify “required” and optional/recommended sections of content and develop clear descriptions • Create best practice content (review, finalize) • Repeat above process for format/structure • Create proposed template for Data Guide We are here

5. Data Guide Project Plan (2) Project Plan: • Proposal to FDA via sub-team representative • Create master Data Guide incorporating FDA feedback • Review/Finalize • Next Steps

6. Action Items from June 18 Meeting Next Steps: Volunteers • Create Phuse wiki account • Add a reply to the “Getting Familiar with the Wiki” discussion • Review Data Guide Analysis and Examples • Provide feedback on Doug Warfield’s example • Contribute to the “Data Guide Content” discussion • Add additional discussion topics as needed

7. Discussion Questions • Discussion questions (# posts) • FDA’s proposed Data Guide template (10) • Other Data Guide examples (1) • Data Guide content (6) • ADaM Data Guide content (0) • Summary • 8 people posted comments • Focus was on SDTM rather than ADaM • Overlap in response content across questions

8. Discussion Question Responses • Categorization of responses based on FDA template TOC • General comments • Study level information • Data description • Annotated CRF (aCRF) • Dictionaries/Codelists (CT) • Domains • Data validation

9. Discussion Question Responses - General • Generally positive comments on the template but many comments/concerns on details of content • Majority of respondents questioned duplication of information found in SDTM documentation, define.xml, or elsewhere in submission • Suggestions to focus on information unique to the trial or clarify areas of potential confusion • One comment at CSS regarding documenting software versions

10. Discussion Question Responses – Study Level • Study design section • Intent not clear • Not valuable to duplicate standard info from SDTMIG • Could be useful to explain study-specific modeling in Trial Design domains • Protocol specifics: Intent of section not clear • Assignment errors? Dosing errors? • Study description, chronology, history • General concern about duplication of info found elsewhere in submission • Describe SDTM and CT versions submitted

11. Discussion Question Responses – Data Description • aCRF • Indicate if there are multiple data sources (secondary CRFs for substudy, diary, etc) • Indicate other data sources/forms not included in SDTM (e.g., operational forms processed by other functions such as SAEs) • Explain any annotation conventions that might not be obvious to reviewers • CT • Intent of section not clear • Could be used to describe sponsor extensions to CDISC CT or mapping of collected terms to standard CT • Comment on level of adherence to CDISC CT • Move after Domains section?

12. Discussion Question Responses – Data Description • Domains • Focus on non-standard information; avoid duplication of define.xml • Custom domains • “Odd” mapping situations • Derived domains (e.g., EX) • Describe domains of primary importance • Whether data on screen failures submitted • Whether any domains not submitted due to no data • Explain data found in SUPP--, FA, RELREC • Assignment errors • Data cutoff

13. Discussion Question Responses – Data Validation • General agreement that this section is valuable • Need guidance on format of report • Can annotated report from review tool be submitted? • Submit the complete report or some subset? • What is an appropriate level of detail in explaining “errors”

14. Next Steps • Form three work groups to further define intended content and organization of content • Study level • Data description • Data validation • Sub-team leads to compile updated template • Sub-team members to pilot template and bring results back to work group • Obtain comment from sub-team and FDA • Finalize and publish template Volunteers needed!

15. Questions