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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 Q4 2021 
White Paper Q22022Q4 2022


Status
colourBlue
titleCurrent Status
Q12022 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
Currently working on draft White Paper 





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