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Project Scope

This project team will create a 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 Navarronavarrom@gene.com 
Nancy Brucken 

nbrucken@csg-inc.com

Paula Rowley (PHUSE Project Assistant)paula@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

Final Paper



Q12021

Q22021



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


Status
colourBlue
titleCurrent Status
 Q22021 Q3/42021

Publication of white paper expected in late Q4 or early Q1, depending on PHUSE resources.  Also investigating publishing in Pharmaceutical Statistics, and submitting to PharmaSUG 2022. White paper went out for public review. Review period has been extended to allow for expected feedback from the FDA. Hoping to have this finalised for Q3.