1. Maintaining the Clinical & Nonclinical Study Data Reviewer’s Guides
2018 CSS Workshop:
Maintaining the Clinical & Nonclinical Study Data Reviewer’s Guides
A Cross-Working Group Collaboration
Nonclinical Topics – Debra Oetzman and Susan DeHaven
Optimizing the Use of Data Standards – Jane Lozano and Lisa Brooks

2. Workshop Agenda Why Have a Workshop Objectives of Workshop
Scope of Workshop Discussions
Breakout Plan
Conclusion/Next Steps
6:30
Workshop Introduction
15 minutes
6:45
Group Breakout
35 minutes (incl. set up)
7:20
Report out/assessment
30 minutes
7:50
Conclusion/next steps
10 minutes

3. Why Have a Workshop?
The PhUSE WGs have developed these templates/guides with a commitment to maintain them for regulatory agency reference
Maintenance of the SDRG packages is needed to assure alignment with guidance
Accurate links in FDA’s Technical Conformance Guide (TCG) are essential
Industry and Regulatory Agency experiences are bringing new ideas for better value
Need to improve ways to get public comments and suggestions on SDRGs as a valuable resource for improving the packages
Desire to improve the consistency, communication, and availability of SDRG packages* for Industry use
* the SDRG “packages” = template, how-to guide, and examples

4. Objectives of the Workshop
Define requirements for ongoing maintenance of the SDRG packages to be consistent with any references in regulatory agency Technical Conformance Guide(s)
Define best practices for communication about the SDRG packages, as well as comments to and from industry users
Define an action plan for implementation of recommendations and action for March TCG update

5. Scope of Discussion In scope - Process Out of scope- Content
What roles are needed to review TCG for changes that affect SDRG.
What is the process for making package changes?
Where will the final products be located?
Where will the in-progress products be located?
What are the best methods for communications?
Out of scope- Content
Names of people who will review.
What are the changes?
What tool(s) will be used
What specific topics will be in the communications.

6. Breakout Plan Break into groups - 1 group/question Answer questions
SDRG Maintenance Requirements
What tasks are needed to maintain the SDRGs?
How can the maintenance be resourced?
Public requirements to find the PhUSE SDRG packages
Desired timing of PhUSE template updates and notifications
Findability, Access, Reusability requirements
How to receive and manage public comments on SDRGs
Assess available tools and recommend procedure
Report Out and Group Assessment

7. Conclusion/Next Steps
Agree on list of workshop recommendations
Final discussion:
Are these recommendations applicable going forward to ADRG, SDSP, and possibly other deliverables referenced by the FDA in TCG or other guidance materials?
Any final thoughts?
Pass recommendations to nSDRG project team and ODS working group leaders

8. Thank you for your participation!
Debra Oetzman:
Jane A Lozano:
(note underscores exist in spaces)