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 (Surface Oncology)Basile, Coherus Biosciences | abasile@surfaceoncology | |
Mary Nilsson | (, Eli Lilly | )||
Nicola Newton, PHUSE Project Assistant | )katie@phuse |
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|---|---|---|---|---|---|---|
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| Published Deliverables | Date |
|---|---|
| Blog – Investigator Assessment of Causality – Opportunity for Simplification? | 15-Dec-2021 |
| 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 |
| Miri Kramer | Mediwound |
| Patrick Hannon | MMS |
| Pranab Mitra | Industry |
| Robin White | Eli Lilly |
| Tatiana Roberson | Unither | William Palo | AbbVie
| Objectives & Deliverables | Timelines |
| Publish White Paper | Q2 2024 |