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 blogQ4 2021 
White Paper Q4 2022


Q2/3 2022

  • Presented the Investigator-determined Causality Issue during April PHUSE Webinar Wednesday
  • Working on a poster for PHUSE/ FDA CSS 2022. Title is: Proposing the Change to Collect Investigator-determined Causality to Only Serious AE's
  • Draft White Paper out for review


Published DeliverablesDate
Blog – Investigator Assessment of Causality – Opportunity for Simplification? 15-Dec-2021
Adverse Event Collection & Treatment Emergent Collection: Version 1.0 27-Aug-2020




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