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Project Scope

This project team will create a paper with recommendations for listings to include in Clinical Study Reports based on shared learning from cross-industry participants, to address changes in data availability over time.

Project LeadsEmails
Nancy Brucken 

nbrucken@csg-inc.com

Mercy Navarro 

navarrom@gene.com 

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.global

DeliverablesTimelines
White Paper providing recommendations for listings to include CSRs and submissions (if any), with a summary of example alternatives to static listings

Public review - Q12021

Final paper - Q22021

Project MembersCompany
Anna LeathEli Lilly
Kim MusgraveAmgen
Maria DaltonGSK
Mary NilssonEli Lilly
Raj PhadtareCorvus Pharma

CURRENT STATUS Q12021

Draft paper almost ready to be shared with Working Group Leads​

Presenting at the FDA Quarterly meeting on 7th April​

Project Lead writing abstract for CDISC Interchange

 
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