Project | ScopeScope | |
This project team will create a White Paper with recommendations for | adverse event collection instructionsAdverse Event Collection Instructions, with a focus on Phase 2-4 clinical trials. This | White Paper will 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 |
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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 |
Adverse Event Collection & Treatment Emergent Collection: Version 1.0, 27-Aug-2020