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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.

Project Leads	Email
Ellen Asam (Merk)	ellen_asam@merck.com
Sandy VanPelt Nguyen (Pfizer)	sandra.vanpeltnguyen@pfizer.com
Katie Warren (PHUSE Project Assistant)	katie@phuse.global

Q1 2023

Objectives & Deliverables	Timelines
Survey	Q1 2022
Summarise survey results in a White Paper	Q2/3 2022
Poster at PHUSE/FDA CSS	Q3 2022
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	Publish White Paper

Status

colour	Blue
title	Current Status

Q3/4 2022
Q1 2023

Drafting white paper and continuing work that was done on PHUSE/FDA CSS Poster and US Connect Presentation

Aiming to complete analysis by Q1 2023

Draft white paper by early Q2 2023

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