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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 LeadsEmail
Ellen Asam, Merckellen_asam@merck.com 
Sandy VanPelt Nguyen, Pfizer

sandra.vanpeltnguyen@pfizer.com

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


Status
colourBlue
titleCurrent Status
Q2 2023 Q3 2023

  • End of October: submit white paper for PHUSE review.

  • November: public review.

  • November/December: publish final paper. 

  • Ongoing work with drafting the White Paper
  • Continuing work that was done on PHUSE/FDA CSS poster and US Connect presentation



Objectives & DeliverablesTimelines
Draft Publish White Paper ready to go through PHUSE review process.Q4 Q2 2023 
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3 2023