1. WG4: Standards Implementation Issues with CDISC Data Models Data 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