Adverse Event Collection Recommendations

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 Leads	Emails
Aimee Basile	abasile@surfaceoncology.com
Mary Nilsson	nilsson_mary_e@lilly.com
Wendy Dobson (PHUSE Project Manager)	wendy@phuse.global

Objectives & Deliverables	Timelines
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

CURRENT 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 Deliverables	Date
Adverse Event Collection & Treatment Emergent Collection: Version 1.0	27-Aug-2020

Project Members	Organisation
Alec Vardy	Jazz Pharma
Andrea Rauch	Boehringer Ingelheim
Cathy Bezek	Astellas
Elisa Young	Southern Star Research
Jeannine Hughes	Boehringer Ingelheim
Jun Li	Sanofi
Kathy Taylor	Unither
Kim Musgrave	Amgen
Kit Howard	CDISC
Laura Goebel	Janssen Research & Development
Patrick Hannon	MMS
Pranab Mitra	Industry
Robin White	Eli Lilly
Tatiana Roberson	Unither
William Palo	AbbVie

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Adverse Event Collection Recommendations