Project Scope |
This project is to evolve |
the Nonclinical 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?
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DehavenLauren White (Alex Pearce, PHUSE Project |
Coordinator)lauren@phuseKey Milestones
Objective | Timeline |
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Maintain the Nonclinical SDRG based on FDA's TCG and any public feedback | Q4 2020 |
Status |
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colour | Blue |
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title | Current Status |
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Completed updates of sections 1-4 of the Reviewer's Guide Completion Guideline. Expected to publish the updated version of the nSDRG template and guide for public review by end of Q4 2020. |
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- Updated version of guide and template based on user feedback. Ready for internal deliverables review; checking to see if FDA wants to review. Present differences from current version at CSS in June; potential for a Wednesday Webinar topic subsequently.
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Published Deliverables |
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nSDRG v1.2 | Version 1.2, 8 April 2022 |
Resources | nSDRG Package | Version 1.1, 17-Mar-2017
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 |
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Anja Metzger | Bayer |
Brett Coupland | AstraZeneca |
Cathy Roy | Merck |
Christy Kubin | MPI Research |
Daniel Potenta | PDS Life Sciences |
Debra Oetzman | Instem |
Deepika V.G | PointCross |
Florence Halbert | Novartis |
Gitte Frausing | Data Standards Decisions |
Hepei Chen | FDA |
Jack Baker | Covance |
Jennifer Abbott | AbbVie |
Jennifer Feldmann | Epreda |
Karen Porter | PointCross |
Kenneth Hershman | Novartis |
Project Members | Organisation |
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Linda Hunt | Merck |
Lindsy Eickhoff | Basinc |
Mandie Rhodes | BMS |
Mark Carfagna | Eli Lilly |
Matthew Whittaker | FDA |
Maureen Rossi | Roche |
Michael Rosentreter | Bayer |
Nicola Robertson | GSK |
Patricia Brundage | FDA |
Paul Brown | FDA |
Rick Thompson | Janssen Research & Development |
Senthil Palani | Xybion |
Steve Polley | GSK |
Susie Lendal Antvorskov | Data Standards Decisions |
Soujanya Konda | Janssen Research & Development |
Tania Smith | Covance |
William Houser | BMS