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 (Project Assistant)	nicky@phuse.global

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

CURRENT STATUS Q2 2023

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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