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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 Q4 2022
Publish White PaperQ2 2023


  • Presented the Investigator-determined Causality Issue during April PHUSE Webinar Wednesday
  • Working towards a draft white paper on adverse event collection recommendations 

    Status
    colourBlue
    titleCurrent Status
    Q3/4 2022

    Q1 2023

    Working on a 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
    Miri Kramer Mediwound
    Patrick HannonMMS
    Pranab MitraIndustry
    Robin WhiteEli Lilly
    Tatiana RobersonUnither
    William PaloAbbVie