Nonclinical Study Data Reviewer's Guide
Project Description |
This project will advance the Nonclinical Study Data Reviewer’s Guide (nSDRG) by incorporating feedback from public PHUSE review and stakeholders, while aligning it with updates to the FDA Technical Conformance Guide. It will also ensure continued consistency with the published CDISC SEND standards and clinical SDRG template developed by the Optimizing the Use of Data Standards Working Group. Because the SDRG is a recommended component of CDISC‑compliant submissions, the project aims to make its creation effective and practical. Key objectives include delivering an accessible template, providing clear guidance on expected content, and offering examples that illustrate how to address common data scenarios. As the work progresses, the team will explore approaches for generating the nSDRG, identify who is best positioned to author it, and assess its usefulness beyond FDA reviewers. The project will also consider how the nSDRG should evolve as organisations gain experience with SEND and as systems mature. |
Project Leads | |
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Janessa Pierce, Merck | |
Sue DeHaven, Sanofi | |
Alex Pearce, PHUSE Project Coordinator |
Click above for the latest project status. |
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. |