Versions Compared

Old Version 37

changes.mady.by.user Kerry Robson

Saved on

compared with

New Version Current

changes.mady.by.user Alex Pearce

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


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.



Katie Warren ()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.

    • Q22021

    Q32021

    Q42021

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

    sandra.vanpeltnguyen@pfizer.com

    Nicola Newton, PHUSE Project Assistantkatie@phuse

    nicky@phuse.global

    Objectives & DeliverablesTimelines

     


    Q3/42021Boehringer Ingelheim 

    Status
    colourBlue
    titleCurrent Status

    • Survey has now been built.
    • Distributing a survey and summarising the results in a White Paper.
    Project MembersOrganisation
    Aimee BasileSurface Oncology
    Brook (Amanda) HinksonMerck
    Carlo RadovskyImmanant
    Cathy YangRoche
    Gayathri MahadevanCytel
    Jennifer JarvisEli Lilly
    Junying ZhangGilead
    Ligia Kilinski CevascoJazz Pharmaceuticals
    Matt Baldwin Amgen
    Parisa Osivand PourIndustry
    Patrick GenynJanssen Research and Development
    Ranvir SinghLabcorp
    Rie IchihashiSanofi
    Rony YeEBSI
    Sathesh AvvaruPPD
    Tingting Tian Regeneron
    Titania Dumas-RobersonUnither Pharmaceuticals
    Todd BazinBiogen
    Torsten Petsching

    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