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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Debra Oetzman | |
Sue DeHaven | |
Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
Objectives and Deliverables | Timelines |
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Maintain the Nonclinical SDRG based on FDA's TCG and any public feedback | Q2 2021 |
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Team review of next template and guide completed, and proposed updates agreed. Release for concurrent public review and FDA review in August. |
Published Deliverables | |
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nSDRG Package | Version 1.1, 17-Mar-2017 |
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 |
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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 Life Sciences |
Florence Halbert | Novartis |
Gitte Frausing | Data Standards Decisions |
Hepei Chen | FDA |
Jack Baker | CovanceLabcorp |
Jennifer Feldmann | Epreda |
Karen Porter | PointCross |
Kenneth Hershman | Novartis |
Kimberley Holich | AbbVie |
Project Members | Organisation |
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Linda Hunt | Merck |
Lindsy Eickhoff | Inotiv |
Mandie Rhodes BMS | Bristol Myers Squibb |
Mark Carfagna | Eli Lilly |
Matthew Whittaker | FDA |
Maureen Rossi | Roche |
Michael Rosentreter | Bayer |
Nicola Robertson | GSK |
Paul Brown | FDA |
Rick Thompson | Janssen Research & Development |
Senthil Palani | Xybion |
Steve Polley | GSK |
Susie Lendal Antvorskov | Data Standards Decisions |
Soujanya Konda | IQVIA |
Tania Smith | CovanceLabcorp |
William Houser BMS | Bristol Myers Squib |