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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

Katie Warren (PHUSE Project Assistant)katie@phuse.global
Objectives & DeliverablesTimelines
  • Build survey.  
  • Distribute survey. Identify contacts within industry to help “spread the word” and solicit participation.
  • Summarise results. 
  • Share the results and propose next steps.

Q22021

Q32021

Q42021

Q22021

CURRENT STATUS Q3/42021

  • Survey has now been built.
  • Distributing a survey and summarising the results in a White Paper.
Project MembersOrganisation
Aimee BasileSurface Oncology
Brook (Amanda) HinksonMerck
Carlo RadovskyImmanant
Cathy YangRoche
Gayathri MahadevanCytel
Jennifer JarvisEli Lilly
Junying ZhangGilead
Ligia Kilinski CevascoJazz Pharmaceuticals
Parisa Osivand PourIndustry
Patrick GenynJanssen Research and Development
Ranvir SinghLabcorp
Rie IchihashiSanofi
Sathesh AvvaruPPD
Tingting Tian Regeneron
Titania Dumas-RobersonUnither Pharmaceuticals
Todd BazinBiogen
Torsten PetschingBoehringer Ingelheim 
Rong YeEBSI
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