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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

Mary Nilsson

Paula Rowley (PHUSE Project Assistant) 
Objectives & DeliverablesTimelines
To create and prioritise a list of potential targets for where alignment would be beneficial.Q12021
An initial version of a White Paper is planned to provide recommendations for some targets.Q42021
Future planning. To have later versions to continue the journey of the process of improving Adverse Event Collection.Beyond 2021


Discussions are progressing in 2 focus areas: relatedness assessment by the investigator, capturing changes in severity.

Finalise the White Paper by Q12022

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
Patrick HannonMMS
Pranab MitraIndustry
Robin WhiteEli Lilly
Tatiana RobersonUnither
William PaloAbbVie
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