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)

abasile@surfaceoncology.com

Mary Nilsson (Eli Lilly)

nilsson_mary_e@lilly.com

Katie Warren (PHUSE Project Assistant)katie@phuse.global 


Objectives & DeliverablesTimelines
AE Relatedness blogQ42021 
White Paper Q22022


Q12022

Currently working on draft White Paper 


Published DeliverablesDate

Adverse Event Collection & Treatment Emergent Collection: Version 1.0 

27-Aug-2020
Blog – Investigator Assessment of Causality – Opportunity for Simplification? 15-Dec-2021




Project MembersOrganisation
Alec VardyJazz Pharma
Andrea RauchBoehringer Ingelheim
Cathy BezekAstellas
Elisa YoungSouthern Star Research
Jeannine HughesBoehringer Ingelheim
Jun LiSanofi
Kathy TaylorUnither
Kim MusgraveAmgen
Kit HowardCDISC
Laura GoebelJanssen Research & Development
Patrick HannonMMS
Pranab MitraIndustry
Robin WhiteEli Lilly
Tatiana RobersonUnither
William PaloAbbVie