Study Data Reviewer s Guide. FDA/PhUSE Project Summary

Transcription

1 Study Data Reviewer s Guide FDA/PhUSE Project Summary

2 Agenda FDA/PhUSE Collaboration Overview Study Data Reviewer s Guide (SDRG) Project Summary

3 FDA/PhUSE Collaboration FDA Proclamation We the Masses Yearning for Answers

4 Paradigm Shift CRO FDA CDISC Pharma Vendor

5 Conferences/Meetings 2.0 A different kind of event Collaborative working meeting Initially defined working groups focused on general topics with projects Work does not stop when people go home continue the collaboration Work products, timelines, next steps

6 Working Group Structure Working Group Steering Committee Consists of 12 members from industry/fda including: liaison to WG Industry/FDA PM Project Reviewers Data Quality FDA Co-Leads Industry Co-Lead Steering Committee Liaison Optimizing Data Standards FDA Co-Leads Industry Co-Lead Steering Committee Liaison Standard Scripts FDA Co-Leads Industry Co-Lead Steering Committee Liaison Non-Clinical Roadmap FDA Co-Leads Industry Co-Lead Steering Committee Liaison Emerging Technologies FDA Co-Leads Industry Co-Lead Steering Committee Liaison Project s Project s Project s Project s Project s

7 Study Data Reviewer s Guide (SDRG) Purpose: Provide FDA Reviewers with additional context and single point of orientation for SDTM datasets submitted as part of ectd Module 5 Project: Standards implementation identified by 2012 FDA/PhUSE WG4 Work Package includes SDRG Template, SDRG Completion Guidelines, SDRG Examples

8 SDRG Work Package (WP) SDRG Template: Structured template designed to facilitate the consistent development of a SDRG SDRG Completion Guidelines: Set of instructions and partial examples designed to aid sponsors developing a SDRG from the template SDRG Examples: Complete SDRG examples developed by SDRG Team members using real-world SDTM data

9 SDRG Content Introduction: SDRG overview and standards inventory Protocol Description: Brief orientation to the study and additional context about the Trial Design Datasets Subject Data Descriptions: Additional context for subject-level datasets that are not adequately documented by define.xml

10 SDRG Content (Cont.) Data Conformance Summary: Inputs used to evaluate SDTM conformance and summary of conformance findings Appendix I: Inclusion/Exclusion Criteria: Full description of inclusion/exclusion criteria if criteria cannot be documented in TI due to SAS v5 limitations Appendix II: Conformance Issues Details Detailed record-level description of conformance issues Sponsors are strongly discouraged from including this section

11 SDRG Project Milestones 18-Mar-12: SDRG Kickoff at FDA/PhUSE CSS 01-Jun-Aug-12: Identification of SDRG content 21-Oct-12: SDRG Core Team F2F 15-Nov-12: 1 st draft of template and completion guidelines posted to PhUSE Wiki 18-Dec-12: Prequalification completed 25-Feb-13: Final WP released for WG4 review 18-Mar-13: v1 provided to FDA CSC

12 SDRG Project Challenges Building the plane while flying Narrowing broad working group focus to discrete projects Technical challenges with online collaboration tools Core Team day jobs Identifying and herding additional volunteers Purposeful Duplication Balancing duplication in the SDRG with other project documentation and single-point of orientation requirement Significant discussions occurred between FDA and industry regarding duplication with the protocol, clinical study report, define.xml, etc.

13 Next Steps Next Steps: CSC to pilot SDRG with sponsors Sponsors are welcomed, but NOT REQUIRED to use the SDRG Work Package to develop SDRGs for their SDTM submissions Analysis Data Reviewer s Guide kicked off at 2013 FDA/PhUSE CSS Additional volunteers are needed - join the team today!

14 Purpose: Analysis Data Reviewer s Guide (ADRG) Provide FDA Reviewers with additional context and single point of orientation for ADaM datasets submitted as part of ectd Module 5 Project: Analysis Data Reviewer s Guide (ADRG) project launched at 2013 FDA/PhUSE CSS

15 ADRG Preview Purpose: Provide FDA Reviewers with additional, human-readable documentation of analysis methods, datasets, and results that cannot be fully explained by ADaM metadata Project Leadership: Susan Kenny (Amgen), Gail Stoner (J&J), Mina Holen (FDA)

16 ADRG Project Tasks Define ADRG Scope Develop draft ADRG template and completion guidelines Vet draft documents Finalize draft ADRG template, completion guidelines and ADRG examples Release ADRG Work Package for public comment Finalize ADRG Work Package and release for use

17 Acknowledgements SDRG Core Team: Steve Wilson, FDA Helena Sviglin, FDA Douglas Warfield, FDA John Brega, Pharmastat Joanna Koft, Biogen-Idec Gail Stoner, Johnson & Johnson Scott Bahlavooni, Genentech David Brega, Pharmastat