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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

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 

Q2

Q3


Q4

Q12020

CURRENT STATUS Q12021

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 YeEBSI
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