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Project Scope

This project team will create a

paper

White 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
Mercy Navarro navarrom@gene.com 
Nancy Brucken 

nbrucken@csg-inc.com

Mercy Navarro 

navarrom@gene.com 

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.global


Objectives & 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 MembersCompanyOrganisation
Anna LeathEli Lilly
Kim MusgraveAmgen
Maria DaltonGSK
Mary NilssonEli Lilly
Raj PhadtareCorvus Pharma


Status
colourBlue
titleCurrent Status
 Q12021

Draft paper White Paper almost ready to be shared with Working Group Leads​Presenting . Presented at the FDA Quarterly meeting on 7th April​. Project Lead writing abstract for CDISC Interchange