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
Optimizing the Use of Data Standards – Jane Lozano

2. 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

3. 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

4. Workshop Agenda Agenda:
Chairs: Debra Oetzman (nsdrg) and Jane Lozano (csdrg)
Maximum capacity: XX
Agenda:
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
Action plan to implement recommendations

5. Workshop Outcomes What are SDRG maintenance tasks?
How to resource maintenance of SDRGs?
Timing of updates?
Findability, accessability, reusability?
Requirements for communication and feedback tools?

6. SDRG Maintenance Tasks
Monitor and arbitrate from all sources of update:
FDA
TCG for new or changed recommendations to sdrg
Study Data Catalog for types of studies (for sdrg examples)
Validation Rules
Public
Public review comments
Submissions to PhUSE FAQs
CDISC
New/updated standards affecting sdrg packages (with FDA topics)
Determine if input is clinical or nonclinical relevant, or BOTH and align.
Update SDRG package considering input from these sources

7. Resourcing Maintenance
TCG
TCG
2 maintenance teams
Establish a common “repository” for C & N SDRG comments to come into teams
Common access to input
Input managed by C or N or jointly as appropriate.
Create joint task force to handle topics mutual to both
Designate a “technical team” to manage public facing communication
Study Data Standards Catalog
Inputs for change
Public Comment
Common C & N comment receipt place
CSDRG Team
NSDRG
Team
Common topics
Arbitrate NSDRG topics
Joint Task Force
i.e. Validation Rules
Arbitrate CSDRG topics
i.e. LDCP
Technical Team

8. Timing of SDRG Updates Updates every 1-2 years at least
Changes can be collected and implemented periodically.
Does not necessarily need to be on same schedule as TCG
Changes in TCG may not always drive a change to SDRG.
Even if no change, recommend to update version number to indicate a review has been done.
Considerations:
Evaluate based on updates or change suggestions, then determine when to perform update.
Too frequent updates can be stressful to industry stakeholders (i.e changes to tools generating SDRG.)

9. Finding, Accessing, Reusing Template packages
Findability
Must be easy to locate with common search engines
Keep in PhUSEwiki.org
Suggest title: “Submission Document Templates”
Avoid multiple locations
eCTD to point to PhUSE wiki
Reusability
“Every download capture so ed and send update to person who downloaded each doc”????

10. Tool Requirements Features for a tool Categorization of Q’s
E.g. feedback, submission related, q’s, etc (what)
Subscription based on an idea
Scoring on priorities?
Granular categorization (where)
Search on questions
Rating like reddit on the question
Response rating => goes to top
Response from PhUSE or Community/ anonymized

11. Action Plan Post Workshop activity
ODS WG to discuss clinical approach in Tues CSS session….
nSDRG team to discuss in following team meeting
Action plan meeting to be scheduled to decide and coordinate clinical, nonclinical and PhUSE actions.

12. Debra Oetzman: debra.oetzman@instem.com
Jane A Lozano:
(note underscores exist in spaces)