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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 blogQ4 2021 White Paper 
Publish White PaperQ2 2023
Q4 2022


Status
colourBlue
titleCurrent Status
Q3/4 2022 Q1 2023

Working on a White Paper

  • 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