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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 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

 

, Coherus Biosciences

abasile@surfaceoncology

abasile@coherus.com

Mary Nilsson, Eli Lilly

nilsson_mary_e@lilly.com

Wendy Dobson (

Nicola Newton, PHUSE Project

Manager)

Assistant

wendy@phuse.global

Objectives & DeliverablesTimelinesTo create and prioritise a list of potential targets for where alignment would be beneficial.Q12021An initial version of a White Paper is planned to provide recommendations for some targets.Q42021Future planning - to have later versions to continue the journey of the process of improving Adverse Event Collection.Beyond 2021

nicky@phuse.global


Status
colourBlue
titleCurrent Status

 Q12021The project scope has now been defined and the team are working through 'site feedback' to establish if this will be incorporated into their survey or not.

Q1 2024

  • The AE collection white paper went out for public review – comments due 14 February.   


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