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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.



Wendy Dobson ( Manager)
Project LeadsEmail
Ellen Asam, Merckellen_asam@merck.com 
Sandy VanPelt Nguyen, Pfizer

sandra.vanpeltnguyen@pfizer.com

Nicola Newton, PHUSE Project Assistant

wendy@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 


Q12021EBSI

Status
colourBlue
titleCurrent Status

Project kicked off this quarter, and presented at the February Webinar.

Team meet bi-weekly and have started work on drafting a survey.

If you would like to contribute to this project email: workinggroups@phuse.global.

Project MembersOrganisation
Aimee BasileSurface Oncology
Brook (Amanda) HinksonMerck
Carlo RadovskyImmanant
Cathy YangRoche
Gayathri MahadevanCytel
Jennifer JarvisEli Lilly
Junying ZhangGilead
Ligia Kilinski CevascoJazz Pharmaceuticals
Nick DeDonderBusiness & Decision Life Sciences
Ranvir SinghCovance
Rie IchihashiSanofi
Sathesh AvvaruPPD
Tingting Tian Regeneron
Titania Dumas-RobersonUnither Pharmaceuticals
Todd BazinBiogen
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