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Scope |
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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:
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 |
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Key Milestones
Objective | Timeline |
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Prioritised list of domains/variables required for harmonisation | Q3 2020 |
Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as needed | Q2 2021 |
Poster presentation and update of current working group progress at CSS | Q2 2021 |
PHUSE Publication or white paper | Q2 2021 |
Status | ||||
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Resources | |
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Vehicle Components Survey | Draft White Paper |
SEND Package A | |
SEND Package B | |
SEND Package C | |
SEND Package D |
Project Members | Organisation |
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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 |
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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 | J&J |
Senthil Palani | Xybion |
Steve Polley | GSK |
Susie Lendal Antvorskov | Data Standards Decisions |
Tania Smith | Covance |
William Houser | BMS |