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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 .



Wendy Dobson ( Manager)wendy@phuse

Build survey  

Distribute survey. Identify contacts within industry to help “spread the word” and solicit participation

Summarize 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

DeliverablesTimelines

 


Q2

Q3

Q4

Q12020

Q12021EBSI

Status
colourBlue
titleCurrent Status

This 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
Project MembersCompany
Aimee BasileSurfaceoncology
Brook (Amanda) HinksonMerck
Carlo RadovskyImmanant
Cathy YangRoche
Gayathri MahadevanCytel
Jennifer JarvisEli Lilly
Ligia Kilinski CevascoNektar Therapeutics
Nick DeDonderBusiness Decisions Life Sciences
Ranvir SinghCovance
Rie IchihashiSanofi
Sathesh AvvaruPrahs
Tingting Tian Regeneron
Titania Dumas-RobersonUnither
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