| Project Scope |
|---|
The scope of this project is to identify a primary and backup representative for each PHUSE regulatory referenced deliverable that will:
The project team will meet quarterly with the ODS Working Group leads to discuss potential updates and the timing of them to avoid burdening the project team members and also regulatory authorities in reviewing the updated deliverables |
| Project Statement |
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The Optimizing the Use of Data Standards Working Group is responsible for the maintenance of four Regulatory Referenced Deliverables (cSDRG, ADRG, SDSP, BDRG) as well as three that will be published in the future. There is no regular maintenance process for updating these deliverables due to updates to binding and non-binding guidance from regulatory authorities. The project teams that were formed to create the documents no longer meet on a regular basis. This project will address the issue of implementing scheduled updates to these deliverables. It is important to be in compliance with the guidances from regulatory authorities. |
| Project Impact | |
|---|---|
| Regulatory authorities reference the deliverables within their guidance documents. The deliverables must be in alignment with the guidance documents. Stakeholders include regulatory authorities and organisations that create the regulatory referenced deliverables. FDA expects sponsors to submit the deliverables utilising the templates that PHUSE creates. Included in the PHUSE deliverables are the templates, example documents, and completion guidelines. |
| Project Leads | |
|---|---|
Jane Lozano (Eli Lilly) | lozano_jane_a@lilly.com |
Janet Low (Merk) | janet_low@merck.com |
Katie Warren (Project Assistant) | katie@phuse.global |
CURRENT STATUS Q3/4 2022 |
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Project approved Q3 2022. Kick off will occur Q1 2023. |