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Project Scope

Best practices 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 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.



Wendy Dobson ( Manager)wendy@phuse
  • Build survey  
    • Distribute survey. Identify contacts within industry to help “spread the word” and solicit participation
  • Summarize results 
  • Share the results and propose next steps 

    • Q22021

    Q32021

    Q42021

    Q22021
    Project LeadsEmail
    Ellen Asam, Merckellen_asam@merck.com 
    Sandy VanPelt Nguyen, Pfizer

    sandra.vanpeltnguyen@pfizer.com

    Nicola Newton, PHUSE Project Assistant

    nicky@phuse.global

    Objectives & DeliverablesTimelines

     


    Q12021EBSI

    Status
    colourBlue
    titleCurrent Status

    Project kicked off this quarter and presented at the February Webinar. Team meet bi-weekly and have started work on a survey.
    Project MembersOrganisation
    Aimee BasileSurfaceoncology
    Brook (Amanda) HinksonMerck
    Carlo RadovskyImmanant
    Cathy YangRoche
    Gayathri MahadevanCytel
    Jennifer JarvisEli Lilly
    Junying ZhangGilead
    Ligia Kilinski CevascoJazz Pharma
    Nick DeDonderBusiness Decisions Life Sciences
    Ranvir SinghCovance
    Rie IchihashiSanofi
    Sathesh AvvaruPrahs
    Tingting Tian Regeneron
    Titania Dumas-RobersonUnither
    Todd BazinBiogen
    Rong Ye

    Q3 2024

    • White paper finalised.

    • Currently going through PHUSE editing/publishing process.



    Objectives & DeliverablesTimelines

    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