Nonclinical Study Data Reviewers Guide

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Welcome the Nonclinical Study Data Reviewers Guide project Wiki!
The nSDRG package has been developed by this team and is available for public use:

  • Nonclinical Study Data Reviewers Guide - TEMPLATE
  • Nonclinical SDRG Guide with recommendations on how to use the template
  • Sample Nonclinical SDRG's developed by team members

Click here to access the Nonclinical SDRG Package V1.1.

The Nonclinical SDRG package has been developed to comply with the FDA's Study Data Technical Conformance Guide

Learn more about Nonclinical Topics Working Group of the PhUSE Computational Sciences Symposium, and its other projects @Nonclinical Topics Working Group.

Purpose

This year's project is to:

  • continually maintain the Nonclinical Study Data Reviewers Guide (nSDRG), based on FDA's Technical Conformance Guide
  • provide guidance on "best practices" for creating nSDRG
  • compare with anticipated potential requirements for Japanese regulatory submissions (new for 2017)
  • maintain alignment with the cSDRG, maintained by Optimizing the Use of Data Standards Working Group for Clinical Studies


Overview and Scope

Preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. The challenge is to operationalize this new documentation requirement efficiently and effectively.
Challenges we seek to answer with this project:

  • Provide a practical template for easy access and use
  • Provide guidance document which describes expected content and options to guide nonclinical SDRG authors.
  • Provide authors with examples, describing how to handle different data situations with SDRG content.

Things we expect to learn along the way:

  • Exploration of ways to generate the nonclinical SDRG and who should do the job.
  • The SDRG is expected to be useful by FDA reviewers. Can it also be useful for other nonclinical study stakeholders?
  • Will the SDRG evolve as systems and processes gain expertise in the new SEND requirements for submission of nonclinical data?


Current Published nSDRG Package

The current package is available here, for public use. Study_Data_Reviewer's_Guide

The package has been reviewed through a PhUSE public deliverable review in 2015, and an FDA review in 2016. Comments from these reviews, as well as from the FDA "Fit for Use" SEND Pilot are being incorporated into the next version of the package. Stay tuned for update announcements.

Project Team

Name Role Organization E-mail
Susan DeHaven Co-Lead, pharma Sanofi susan.dehaven@sanofi.com
Debra.Oetzman Co-Lead, software vendor Instem debra.oetzman@instem.com
Paul Brown Team member US FDA paul.brown@fda.hhs.gov
Susie Lendal Antvorskov Team member Data Standards Decisions slendal@datastandardsdecisions.com
William Houser Team member BMS william.houser@bms.com
Jennifer Feldmann Team member Instem jennifer.feldmann@instem.com
Steve Polley Team member GSK steven.r.polley@gsk.com
Nicola Robertson Team member GSK nicola.j.robertson@gsk.com
Tania Strimple Team member Covance tania.strimple@Covance.com
Cathy Roy Team member Merck catherine.roy@merck.com
Linda Hunt Team member Merck linda.hunt@merck.com
Patricia Brundage Team member FDA patricia.brundage@fda.hhs.gov

Plans

Projects:

  • Implement the visioning process agree upon with PhUSE
  • Review and adapt as needed, comments provided by FDA from Public Review
  • Establish ongoing maintenance process
  • Better address Section 6 for Legacy Data Conversion
  • Review, and adapt as needed, to periodic revisions of Technical Conformance Guide
  • Develop new example studies for new types included in SEND 3.1
  • Maintain alignment with Clinical version



Meeting Plan:

  • Biweekly meetings are now held to work through template and guidance development


Deliverables

Next SDRG package

Next Meeting

We meet biweekly on Thurs at 11am Eastern time.
To be invited, please contact: Debra Oetzman or Susan DeHaven
You will be welcomed!

Conference Calls and Minutes

Nonclinical SDRG pilot project meeting minutes

Call for Members

People likely interested in our topic: Toxicologists, Data managers preparing SEND data sets, Nonclinical study reviewers (FDA, Sponsor or other), relevant software vendors. What is the commitment?

  • Time will vary with a minimum of 1 hour, every 2 weeks for meeting attendance + 1-2 hours between for authoring, reviewing and assessing outcomes.
  • Attendance to the PHUSE Computational Sciences Symposium conference is not required.

If you would like to participate, please contact one of the Project Co-leads.


Working Documents

Next Version

Nonclinical SDRG Template and Guide - Working Drafts

Review Comments Tracker

Archive

2015 PhUSE Public Review: Nonclinical SDRG Template and Guide - Drafts for Public PhUSE Review

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