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Project Scope |
Best Practices in Data Standards Implementation Governance will cover the following areas: - Building and maintaining the contents of data standards repositories.
- Extending data standards for individuals projects/studies.
- Maintaining Sponsor extensions to data standards.
- Scope of data standards governance:
- What areas should be covered by governance? (e.g. CRF, external data, tabulation, analysis, RWE, etc…).
- What should be governed centrally vs permitted on studies?
- Feedback/communication to/with SDOs.
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- Ongoing work with drafting the White Paper
- Continuing work that was done on PHUSE/FDA CSS poster and US Connect presentation
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| Objectives & Deliverables | Timelines |
| Draft White Paper ready to go through PHUSE review process | Q2 2023 |
| Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedback | Q3 2023 |
