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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.



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

     

    Q22021

    Q32021

    Q42021

    Q22021


    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 drafting a survey.

    If you would like to contribute to this project email: workinggroups@phuse.global.

    Project MembersOrganisation
    Aimee BasileSurface Oncology
    Brook (Amanda) HinksonMerck
    Carlo RadovskyImmanant
    Cathy YangRoche
    Gayathri MahadevanCytel
    Jennifer JarvisEli Lilly
    Junying ZhangGilead
    Ligia Kilinski CevascoJazz Pharmaceuticals
    Nick DeDonderBusiness & Decision Life Sciences
    Parisa Osivand PourIndustry
    Patrick GenynJanssen Research and Development
    Ranvir SinghCovance
    Rie IchihashiSanofi
    Sathesh AvvaruPPD
    Tingting Tian Regeneron
    Titania Dumas-RobersonUnither Pharmaceuticals
    Todd BazinBiogen
    Rong Ye

    Q1 2024

    •  Finishing draft white paper and sending for PHUSE/public reviews



    Objectives & DeliverablesTimelines
    Publish White PaperQ4 2023 
    Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3 2023