| Project Scope This project team will create a 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. |
| Project Leads | Emails |
|---|---|
| Mercy Navarro | navarrom@gene.com |
| Nancy Brucken | |
| Wendy Dobson (PHUSE Project Manager) |
| Objectives & Deliverables | Timelines |
|---|---|
| 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 | Organisation |
|---|---|
| Anna Leath | Eli Lilly |
| Kim Musgrave | Amgen |
| Maria Dalton | GSK |
| Mary Nilsson | Eli Lilly |
| Raj Phadtare | Corvus Pharma |
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|---|
Draft White Paper almost ready to be shared with Working Group Leads. Presented at the FDA Quarterly meeting on 7th April. Project Lead writing abstract for CDISC Interchange |