Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


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 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.



Basile (Surface Oncology)abasile@surfaceoncology ()Katie Warren ()katie@phuse 
Project LeadsEmails

Aimee

Basile, Otsuka Pharmaceutical

Aimee.Basile@otsuka-us

.com

Mary Nilsson

, Eli Lilly

nilsson_mary_e@lilly.com

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global

Objectives & DeliverablesTimelinesPublish White Paper

Q2 2023


Working on a

Status
colourBlue
titleCurrent Status
Q1 2023

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 MembersOrganisationAlec VardyJazz PharmaAndrea RauchBoehringer IngelheimCathy BezekAstellasElisa YoungSouthern Star ResearchJeannine HughesBoehringer IngelheimJun LiSanofiKathy TaylorUnitherKim MusgraveAmgenKit HowardCDISCLaura GoebelJanssen Research & DevelopmentMiri Kramer MediwoundPatrick HannonMMSPranab MitraIndustryRobin WhiteEli LillyTatiana RobersonUnitherWilliam PaloAbbVie