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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.



(Merk)  ()Katie Warren ()
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

 


Aiming to complete analysis by 2023
  • Draft white paper by early Q2 2023
    • Boehringer Ingelheim 
    Objectives & DeliverablesTimelines

    Survey

    Q1 2022

    Summarise survey results in a White Paper Q2/3 2022
    Poster at PHUSE/FDA CSSQ3 2022 
    Publish White Paper Q1 2023 

    Status
    colourBlue
    titleCurrent Status
    Q3/4 2022

    Q1

    Project MembersOrganisation
    Aatiya ZaidiGilead
    Aimee BasileSurface Oncology
    Brook (Amanda) HinksonMerck
    Carlo RadovskyImmanant
    Cathy YangRoche
    Gayathri MahadevanCytel
    Gina WoodeClinical Solutions
    Jennifer JarvisEli Lilly
    Junying ZhangGilead
    Kapil AnandParexel
    Kishore Pothuri Vita Data Sciences
    Ligia Kilinski CevascoJazz Pharmaceuticals
    Matt Baldwin Amgen
    Nicholas Pemble Johnson & Johnson
    Parisa Osivand PourIndustry
    Priyanka Pollarine Biogen
    Ramaiah MuvvalaInductive Quotient
    Ranvir SinghLabcorp
    Rie IchihashiSanofi
    Rony YeEBSI
    Sathesh AvvaruPPD
    Susan Takas Johnson & Johnson
    Tingting Tian Regeneron
    Titania Dumas-RobersonUnither Pharmaceuticals
    Todd BazinBiogen
    Torsten Petsching

    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