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 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 | |
Mary Nilsson | |
| Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
| Objectives & Deliverables | Timelines |
| To create and prioritise a list of potential targets for where alignment would be beneficial. | Q12021 |
| An initial version of a White Paper is planned to provide recommendations for some targets. | Q42021 |
| Future planning. To have later versions to continue the journey of the process of improving Adverse Event Collection. | Beyond 2021 |
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Discussions are progressing in 2 focus areas: relatedness assessment by the investigator, capturing changes in severity. Finalise the White Paper by Q12022 |
| Published Deliverables | Date |
|---|---|
Adverse Event Collection & Treatment Emergent Collection: Version 1.0 | 27-Aug-2020 |
| Blog – Investigator Assessment of Causality – Opportunity for Simplification? | 15-Dec-2021 |
| 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 |
| Patrick Hannon | MMS |
| Pranab Mitra | Industry |
| Robin White | Eli Lilly |
| Tatiana Roberson | Unither |
| William Palo | AbbVie |