Best Practices in Data Standards Implementation Governance

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.

Project Leads	Email
Ellen Asam, Merck	ellen_asam@merck.com
Sandy VanPelt Nguyen, Pfizer	sandra.vanpeltnguyen@pfizer.com
Nicola Newton, PHUSE Project Assistant	nicky@phuse.global

Current Status Q4 2024

Objectives & Deliverables	Timelines
White Paper Published	Q4 2024
Publish White Paper	Q3 2024
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedback	Q3 2023