Image Modified
| 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. |
| Katie Warren (PHUSE Project |
| 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 |
|---|
PharmaSUG final paper | Q2 2022 |
| PharmaSUG slides | Q2 2022 |
PHUSE US Connect poster | Q2 2022 |
| Status |
|---|
| colour | Blue |
|---|
| title | CURRENT STATUS |
|---|
|
Q3/4 2022 |
|---|
- Received journal submission response with comments to be addressed before publication
- White Paper published on the PHUSE website
|
| Project Members | Organisation |
|---|
| Anna Leath | Eli Lilly |
| Kim Musgrave | Amgen |
| Kirthi Rangaraju | Pfizer |
| Maria Dalton | GSK |
| Mary Nilsson | Eli Lilly |
| Raj Phadtare | Corvus Pharma |
| Status |
|---|
| colour | Blue |
|---|
| title | Current Status |
|---|
|
Q12021 |
|---|
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