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Project

Scope

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

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

 

, Coherus Biosciences

abasile@surfaceoncology

abasile@coherus.com

Mary Nilsson, Eli Lilly

nilsson_mary_e@lilly.com

Wendy Dobson (

Nicola Newton, PHUSE Project

Manager)

Assistant

wendy@phuse

nicky@phuse.

eu

global


Status
colourBlue
titleCurrent Status

 Q42020New team formed this quarter and kick off meeting taken place. Presented at the recent CSSResources

Q1 2024

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


Published DeliverablesDate
Blog – Investigator Assessment of Causality – Opportunity for Simplification? 15-Dec-2021
Adverse Event Collection & Treatment Emergent Collection:
 White Paper - 
Version 1.
0,
0 27-Aug-2020




Objectives & DeliverablesTimelines
To create and prioritise a list of potential targets for where alignment would be beneficialQ12021An initial version of a White Paper is planned to provide recommendations for some targetsQ42021Future planning - to have later versions to continue the journey of the process of improving Adverse Event CollectionBeyond 2021
Publish White PaperQ2 2024
Project MembersCompanyAlec VardyJazzpharmaCathy BezekAstellasElisa YoungSouthernStarResearchJeannine HughesBoehringer IngelheimJun LiSanofiKathy TaylorUnitherKim MusgraveAmgenKit HowardCDISCLori Van MeterJanssen Research & DevelopmentPatrick HannonMMSPranab MitraIndustryRobin WhiteEli LillyTatiana RobersonUnitherWilliam PaloAbbVie