Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


Project Scope 

This project team will create a White Paper with recommendations for Adverse Event Collection Instructions, with a focus on Phase 2-4 clinical trials. This project will build upon a paper that outlines results from a survey on current practices, indicating variation that can likely be reduced. Recommendations will be based on the desired end-in-mind, and may or may not be consistent with current practices.



Project LeadsEmails

Aimee

Basile (Surface Oncology)

Basile, Coherus Biosciences

abasile@coherus

abasile@surfaceoncology

.com

Mary Nilsson

(

, Eli Lilly

)Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse Objectives & DeliverablesTimelinesPublish White PaperQ2 2023


Status
colourBlue
titleCurrent Status
Q1

2023Working on a White Paper

2024

  • The AE collection white paper went out for public review – comments due 14 February.   


Project MembersOrganisationAlec VardyJazz PharmaAndrea RauchBoehringer IngelheimCathy BezekAstellasElisa YoungSouthern Star ResearchJeannine HughesBoehringer IngelheimJun LiSanofiKathy TaylorUnitherKim MusgraveAmgenKit HowardCDISCLaura GoebelJanssen Research & DevelopmentMiri Kramer MediwoundPatrick HannonMMSPranab MitraIndustryRobin WhiteEli LillyTatiana RobersonUnither




Objectives & DeliverablesTimelines
Publish White PaperQ2 2024
William PaloAbbVie