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Project

Scope

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

 abasile@surfaceoncology

, Otsuka Pharmaceutical

Aimee.Basile@otsuka-us.com

Mary Nilsson, Eli Lilly

nilsson_mary_e@lilly.com

Wendy Dobson (

Nicola Newton, PHUSE Project

Manager)

Assistant

wendy@phuse

nicky@phuse.global


Status
colourBlue
titleCurrent Status

 Q42020New team formed this quarter and kick off meeting taken place. Presented at the recent CSSResources

Adverse Event Collection & Treatment Emergent Collection: 

White Paper - Version 1.0, 27-Aug-2020DeliverablesTimelinesTo create and prioritise a list of potential targets for where alignment would be beneficialQ12021An initial version of a White Paper is planned to provide recommendations for some targetsQ42021Future planning - to have later versions to continue the journey of the process of improving Adverse Event CollectionBeyond 2021

Q2 2024

  • Published recommendations in white paper 





Objectives & DeliverablesTimelines
Publish White PaperQ2 2024


Published DeliverablesDate

White Paper - The Adverse Event Collection Recommendations

11-Jun-2024

Blog – Investigator Assessment of Causality – Opportunity for Simplification?

15-Dec-2021
Adverse Event Collection & Treatment Emergent Collection: Version 1.027-Aug-2020
Project MembersCompanyAlec VardyJazzpharmaAndrea RauchBoehringer IngelheimCathy BezekAstellasElisa YoungSouthernStarResearchJeannine HughesBoehringer IngelheimJun LiSanofiKathy TaylorUnitherKim MusgraveAmgenKit HowardCDISCLaura GoebelJanssen Research and DevelopmentPatrick HannonMMSPranab MitraIndustryRobin WhiteEli LillyTatiana RobersonUnitherWilliam PaloAbbVie