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. |
Project Leads | |
---|---|
Sue Dehaven | susan.dehaven@sanofi.com |
Debra Oetzman | debra.oetzman@instem.com |
Key Milestones
Objective | Timeline |
---|---|
Maintain the Nonclinical SDRG based on FDA's TCG and any public feedback | Q4 2020 |
Status | ||||
---|---|---|---|---|
|
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.
Resources | |
---|---|
nSDRG Completion Guidelines | Version 1.1 |
nSDRG Template | Version 1.1 |
Maintaining the Clinical & Nonclinical Study Data Reviewers Guides | CSS 2018 Workshop |
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 Metzger | Bayer |
Brett Coupland | Astrazeneca |
Cathy Roy | Merck |
Christy Kubin | MPI Research |
Daniel Potenta | PDS Lifesciences |
Debra Oetzman | Instem |
Deepika V.G | Point Cross |
Florence Halbert | Novartis |
Gitte Frausing | Data Standards Decisions |
Hepei Chen | FDA |
Jack Baker | Covance |
Jennifer Abbott | Abbvie |
Jennifer Feldmann | Epreda |
Karen Porter | Point Cross |
Kenneth Hershman | Novartis |
Project Members | Organisation |
---|---|
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 | J&J |
Senthil Palani | Xybion |
Steve Polley | GSK |
Susie Lendal Antvorskov | Data Standards Decisions |
Tania Smith | Covance |
William Houser | BMS |
Volunteer Today
Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.