Project | ScopeScope |
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. |
Nicola Newton, 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 |
| Status |
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| colour | Blue |
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| title | Current Status |
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Discussions are progressing in 2 focus areas: relatedness assessment by the investigator, capturing changes in severity.
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- Published recommendations in white paper
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| Objectives & Deliverables | Timelines |
| Publish White Paper | Q2 2024 |
| 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 |
| Patrick Hannon | MMS |
| Pranab Mitra | Industry |
| Robin White | Eli Lilly |
| Tatiana Roberson | Unither |
William Palo | AbbVie
