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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

 abasile@surfaceoncology

, Otsuka Pharmaceutical

Aimee.Basile@otsuka-us.com

Mary Nilsson, Eli Lilly

nilsson_mary_e@lilly.com

Paula Rowley (

Nicola Newton, PHUSE Project Assistant

)

paula@phuse

Status
colourBlue
titleCurrent Status
 Q12021

The 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.Published DeliverablesDate

nicky@phuse.global


Status
colourBlue
titleCurrent Status
Q2 2024

  • Published recommendations in white paper 





Objectives & DeliverablesTimelines
To 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
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.
0 
027-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 RobersonUnitherWilliam PaloAbbVie