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)

Mary Nilsson (Eli Lilly)

Katie Warren (PHUSE Project Assistant) 
Objectives & DeliverablesTimelines
AE Relatedness blogQ4 2021 
White Paper Q4 2022


  • Presented the Investigator-determined Causality Issue during April PHUSE Webinar Wednesday
  • Working towards a draft white paper on adverse event collection recommendations 
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
Miri Kramer Mediwound
Patrick HannonMMS
Pranab MitraIndustry
Robin WhiteEli Lilly
Tatiana RobersonUnither
William PaloAbbVie
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