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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 |
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 |
abasile@surfaceoncologyWendy Dobson (Nicola Newton, PHUSE Project |
Manager)wendy@phuseeu
Status |
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colour | Blue |
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title | Current Status |
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Q42020New team formed this quarter and kick off meeting taken place. Presented at the recent CSS |
Resources |
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- The AE collection white paper went out for public review – comments due 14 February.
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0, White Paper |
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 |
Publish White Paper | Q2 2024 |
Project Members | Company |
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Alec Vardy | Jazzpharma |
Cathy Bezek | Astellas |
Elisa Young | SouthernStarResearch |
Jeannine Hughes | Boehringer Ingelheim |
Jun Li | Sanofi |
Kathy Taylor | Unither |
Kim Musgrave | Amgen |
Kit Howard | CDISC |
Lori Van Meter | Janssen Research & Development |
Patrick Hannon | MMS |
Pranab Mitra | Industry |
Robin White | Eli Lilly |
Tatiana Roberson | Unither |
William Palo | AbbVie