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. |
| Project Leads | Emails |
|---|---|
Aimee Basile, Otsuka Pharmaceutical | |
Mary Nilsson, Eli Lilly | |
Nicola Newton, PHUSE Project Assistant |
| The AE collection white paper went out for public review – comments due 14 February. ||||||
|---|---|---|---|---|---|---|
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| Objectives & Deliverables | Timelines |
| Publish White Paper | Q2 2024 |
| Published Deliverables | Date |
|---|---|
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 | 27-Aug-2020 |