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Project Scope 

The goals of this project is to obtain broad industry and CRO feedback on the current publicly available OCE/OOD standard safety data request (found at: https://www.fda.gov/media/133252/download) and assist with the development of resources to assist Sponsors with implementation of these data specifications.

There is tremendous variability and inconsistency in the use of the CDISC ADaM data standard in safety datasets for oncology NDA/BLA applications submitted to FDA. This variability leads to inefficiency in review for the FDA and multiple information requests to applicants during the course of the review to resolve inconsistencies in analyses between FDA and applicants. The Oncology Centre of Excellence (OCE)/Office of Oncologic Diseases (OOD) has developed a pilot standard safety data request for datasets submitted with NDA/BLA applications and instructions for conducting select safety analyses to create a common set of data elements with common use of these variables for safety analyses. The Stakeholders include FDA reviewers and analysts, industry, CROs, and software developers.

CURRENT STATUS Q1 2022

  • This project is currently on hold, the team will reach out for volunteers for the kick off of phase 2. 
Project LeadsEmail
Abhilasha Nairabhilasha.nair@fda.hhs.gov
Chris Pricechris.price@phuse.global 
Peter Schotland

peter.schotland@fda.hhs.gov

Katie Warren

(PHUSE Project Assistant)

katie@phuse.global
DeliverablesTimelines
Feedback on publicly available OCE/OOD safety data request.Q22021
Development of basic resources for sponsors to assist implementation (e.g. CRF design to collect relevant data and linkages for adverse events and dataset preparation for laboratory analyses or other resources requested or found to be needed during the feedback process).Q22021
Project MembersOrganisation
Abhinav SrivastvaExelixis
Bhupendra MistryRoche
Bohdan WolosiukPfizer 
Cathy BezekAstellas
Cindy MarabottiSanofi
Diane WoldCDISC
Gopi VegesnaAstellas
Greg Ball  Novavax
Gregory PurnsleyPfizer
Hitesh ThackerLabcorp
Hong QiMerck
Joy GeMerck
Karen YingGSK
Ken MaahsJanssen Research & Development
Kim MusgraveAmgen
Lihui Deng Bristol Myers Squibb
Lindsay McLeanPHASTAR
Marleen NijsJanssen Research & Development
Project MembersOrganisation
Matt SmithPfizer

Maxime Rouch 

Sanofi
Paul FrostGEM Programming
Pavan KumarGSK
Peter Bonata BayerBayer
Sasabindu TripathyTakeda
Srinivas KolamuriNovartis
Suriaya WalshAstraZeneca
Suwen LiRoche

Tatiana Sotingco

Janssen Research & Development
Tim YoungGSK
Venkata Rajesh DatlaGenmab
Vishnu DabbiruGSK
Wenyun JiAbbVie
Whitney BoeckelGSK
William PaloAbbVie
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