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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 


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

    Status
    colourBlue
    titleCurrent Status
    Q2 2023

    Q4 2024

    • White paper published.



    Objectives & DeliverablesTimelines
    Draft White Paper ready to go through PHUSE review processQ2 2023 

    White Paper Published

    Q4 2024

    Publish White Paper

    Q3 2024
    Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3 2023