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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 Navarro (Genentech)navarrom@gene.com 
Nancy Brucken
 nbrucken@csg-incPaula Rowley
Katie Warren (PHUSE Project Assistant)
paula@phuse 


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

PharmaSUG final paper

Q2 2022
PharmaSUG slidesQ2 2022

PHUSE US Connect poster

Q2 2022


Status
colourBlue
titleCURRENT STATUS
Q3/4 2022 

  • Received journal submission response with comments to be addressed before publication
  • White Paper published on the PHUSE website



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

Status
colourBlue
titleCurrent Status
 Q22021

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.