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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.



Paula Rowley ()
  • Build 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 Assistantpaula@phuse

    nicky@phuse.global 

    Objectives & DeliverablesTimelines

    Q22021

    Q32021

    Q42021

    Q22021


    Q22021EBSI

    Status
    colourBlue
    titleCurrent Status

    Still in the process of drafting survey questions. We plan to use CSS sessions to finalise the questions and distribute shortly after, so distribution may fall into October, slightly past planned Q3 delivery.

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