Page History

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.