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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.



Katie Warren ()
Project LeadsEmail
Ellen Asam, Merckellen_asam@merck.com 
Sandy VanPelt Nguyen, Pfizer

sandra.vanpeltnguyen@pfizer.com

Nicola Newton, PHUSE Project Assistantkatie@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

nicky@phuse.global 


Q3/42021EBSI

Status
colourBlue
titleCurrent Status

  • 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 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