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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 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.com

Mary Nilsson

nilsson_mary_e@lilly.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.eu

CURRENT STATUS Q42020

New team formed this quarter and kick off meeting taken place. Presented at the recent CSS
Resources

Adverse Event Collection & Treatment Emergent Collection: 

White Paper - Version 1.0, 27-Aug-2020
DeliverablesTimelines
To create and prioritise a list of potential targets for where alignment would be beneficialQ12021
An initial version of a White Paper is planned to provide recommendations for some targetsQ42021
Future planning - to have later versions to continue the journey of the process of improving Adverse Event CollectionBeyond 2021
Project MembersCompany
Alec VardyJazzpharma
Cathy BezekAstellas
Elisa YoungSouthernStarResearch
Jeannine HughesBoehringer Ingelheim
Jun LiSanofi
Kathy TaylorUnither
Kim MusgraveAmgen
Kit HowardCDISC
Lori Van MeterJanssen Research & Development
Patrick HannonMMS
Pranab MitraIndustry
Robin WhiteEli Lilly
Tatiana RobersonUnither
William PaloAbbVie
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