Best practices 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 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 .
|