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Project Scope |
This project team will create a | paper White Paper with recommendations for listings to include in Clinical Study Reports based on shared learning from cross-industry participants, to address changes in data availability over time. |
Nancy Brucken | nbrucken@csg-incMercy Navarro | navarrom@gene Wendy Dobson Katie Warren (PHUSE Project |
Managerwendy@phuse
Objectives & Deliverables | Timelines |
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White Paper providing recommendations for listings to include CSRs and submissions (if any), with a summary of example alternatives to static listings | Public review - Q12021 Final paper - Q22021 |
Project Members | Company |
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PharmaSUG final paper | Q2 2022 |
PharmaSUG slides | Q2 2022 |
PHUSE US Connect poster | Q2 2022 |
Status |
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colour | Blue |
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title | CURRENT STATUS |
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| Q3/4 2022 |
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- Received journal submission response with comments to be addressed before publication
- White Paper published on the PHUSE website
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Project Members | Organisation |
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Anna Leath | Eli Lilly |
Kim Musgrave | Amgen |
Kirthi Rangaraju | Pfizer |
Maria Dalton | GSK |
Mary Nilsson | Eli Lilly |
Raj Phadtare | Corvus Pharma |
Status |
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colour | Blue |
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title | Current Status |
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| Q12021 |
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Draft paper almost ready to be shared with Working Group Leads
Presenting at the FDA Quarterly meeting on 7th April
Project Lead writing abstract for CDISC Interchange