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Scope

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)

Basile, Coherus Biosciences

abasile@coherus

abasile@surfaceoncology

.com

Mary Nilsson

(

, Eli Lilly

)

nilsson_mary_e@lilly.com

Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse

nicky@phuse.global

 

Objectives & DeliverablesTimelinesAE Relatedness blogQ4 2021 White Paper Q4 2022


Status
colourBlue
titleCurrent Status

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

    • Q1 2024

    • The AE collection white paper went out for public review – comments due 14 February.   
    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 MembersOrganisationAlec VardyJazz PharmaAndrea RauchBoehringer IngelheimCathy BezekAstellasElisa YoungSouthern Star ResearchJeannine HughesBoehringer IngelheimJun LiSanofiKathy TaylorUnitherKim MusgraveAmgenKit HowardCDISCLaura GoebelJanssen Research & DevelopmentPatrick HannonMMSPranab MitraIndustryRobin WhiteEli LillyTatiana RobersonUnither




    Objectives & DeliverablesTimelines
    Publish White PaperQ2 2024
    William PaloAbbVie