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:
Things we expect to learn along the way:
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Project Leads |
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Sue Dehaven
susan.dehaven@sanofi.com
Debra Oetzman, Instem |
Key Milestones
Sue DeHaven, Sanofi | |
Alex Pearce, PHUSE Project Assistant |
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Q2 2024 |
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Published Deliverables | |
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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
Brett Coupland
Cathy Roy
Christy Kubin
MPI Research
Daniel Potenta
Debra Oetzman
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Project Members
Linda Hunt
Merck
Lindsy Eickhoff
Mandie Rhodes
Mark Carfagna