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Project Scope

This project is to evolve the Nonclinical Study Data Reviewer's Guide (nSDRG), based on comments from a public PHUSE review, plus to adapt it to updates of the FDA Technical Conformance Guide. The project continues to check and align with the SDRG template and guide developed by the Optimizing the Use of Data Standards Working Group for clinical studies.

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 operationalise 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?

Project Leads

Email

Debra Oetzman (Instem)

debra.oetzman@instem.com

Sue DeHaven (Sanofi)

susan.dehaven@sanofi.com

Katie Warren (PHUSE Project Assistant)

katie@phuse.global

Objectives & DeliverablesTimelines
Maintain the Nonclinical SDRG based on FDA's TCG and any public feedback Q2 2021 
Publish nSDRG v 1.2Q2 2022


CURRENT STATUS Q2/3 2022

  • Published nSDRG v 1.2 
  • Project currently on hold, resume in Q3 2022 and continue working on example development 
Published Deliverables

nSDRG v1.2 

Version 1.2, 8 April 2022
Maintaining the Clinical & Nonclinical Study Data Reviewers Guides CSS 2018 Workshop


Nonclinical SDRG Package

The Nonclinical SDRG package has been developed to comply with the FDA's Study Data Technical Conformance Guide. The current version of this document can be found at the website: FDA Data Standards Resources. The nSDRG team continues to monitor FDA's Technical Conformance Guide updates (which occur 2X per year, expected in MAR and OCT) and also public comments received from users of nSDRG. As these new inputs are evaluated, we will post answers in the SEND Implementation Forum, and update the published documents as needed. Stay tuned for update announcements.

Project Members 

Organisation 
Anja MetzgerBayer

Brett Coupland

AstraZeneca

Cathy Roy

Merck

Christy Kubin 

MPI Research

Daniel Potenta 

PDS Life Sciences

Debra Oetzman

Instem

Deepika V.G 

PointCross Life Sciences
Florence Halbert Novartis
Gitte Frausing Data Standards Decisions
Hepei Chen FDA
Jack Baker Labcorp 
Jennifer Feldmann Epreda
Karen Porter PointCross
Kenneth Hershman Novartis
Kimberley HolichAbbVie

Project Members 

Organisation 

Linda Hunt 

Merck

Lindsy Eickhoff 

Inotiv

Mandie Rhodes 

Bristol Myers Squibb

Mark Carfagna 

Eli Lilly
Matthew WhittakerFDA
Maureen Rossi Roche
Michael Rosentreter Bayer
Nicola Robertson GSK
Paul Brown FDA
Rick Thompson Janssen Research & Development
Senthil Palani Xybion
Steve PolleyGSK
Susie Lendal Antvorskov Data Standards Decisions
Soujanya KondaIQVIA 
Tania Smith Labcorp

Vishal Jadhav

Xybion
William Houser Bristol Myers Squib
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