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 |
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Aimee Basile (Surface Oncology) | |
Mary Nilsson (Eli Lilly) | |
Nicola Newton (PHUSE, Project Assistant) |
Objectives & Deliverables | Timelines |
Publish White Paper | Q2 2023 |
CURRENT STATUS Q1 2023 |
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Working on a White Paper |
Published Deliverables | Date |
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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 |
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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 |