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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 .



Van PeltWendy Dobson ( Manager)wendy@phuse
Project LeadsEmail
Ellen Asam, Merckellen_asam@merck.com 
Sandy VanPelt Nguyen, Pfizer

sandra.vanpeltnguyen@pfizer.com

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global 


Deliverables

Status

Timelines

colour

White PaperTo be confirmed

Blue
titleCurrent Status

Q12021This is a new project which will commence in January. The team are to fine tune how they wish to approach writing the paper and following the kick off meeting, further updates will be provided

Q1 2024

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



EBSI
Objectives & DeliverablesTimelines
Publish White PaperQ4 2023 
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3 2023
Project MembersCompany
Aimee BasileSurfaceoncology
Carlo RadovskyImmanant
Cathy YangRoche
D KachhiaIndustry
Nick DeDonderBusiness Decisions Life Sciences
Rie IchihashiSanofi
Titania Dumas-RobersonUnither
Ye Rong