Project | ScopeScope |
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 |
, Coherus Biosciences |
Mary Nilsson, Eli Lilly |
Nicola Newton, PHUSE Project Assistant |
|
|---|
Discussions are progressing in 2 focus areas: relatedness assessment by the investigator, capturing changes in severity.
Finalise the White Paper by Q12022
Q1 2024 |
|---|
|
| Published Deliverables | Date |
|---|
Adverse Event Collection & Treatment Emergent Collection: Version 1.0
| Blog – Investigator Assessment of Causality – Opportunity for Simplification? | 15-Dec-2021 |
| Objectives & Deliverables | Timelines |
| Publish White Paper | Q2 2024 |