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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.

Project LeadsEmail
Ellen Asamellen_asam@merck.com 
Sandy VanPelt Nguyen

sandra.vanpeltnguyen@pfizer.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.global

Objectives & DeliverablesTimelines
  • 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 

Q22021

Q32021

Q42021

Q22021

CURRENT STATUS Q12021

Project kicked off this quarter and presented at the February Webinar. Team meet bi-weekly and have started work on a survey.
Project MembersOrganisation
Aimee BasileSurfaceoncology
Brook (Amanda) HinksonMerck
Carlo RadovskyImmanant
Cathy YangRoche
Gayathri MahadevanCytel
Jennifer JarvisEli Lilly
Junying ZhangGilead
Ligia Kilinski CevascoJazz Pharma
Nick DeDonderBusiness Decisions Life Sciences
Ranvir SinghCovance
Rie IchihashiSanofi
Sathesh AvvaruPrahs
Tingting Tian Regeneron
Titania Dumas-RobersonUnither
Todd BazinBiogen
Rong YeEBSI
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