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Project Scope

Best practices 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 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)wendy@phuse

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

Q22021
Project LeadsEmail
Ellen Asam, Merckellen_asam@merck.com 
Sandy VanPelt Nguyen, Pfizer

sandra.vanpeltnguyen@pfizer.com

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global

DeliverablesTimelines

 


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 a survey.
Project MembersCompany
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 Ye

Q3 2024

  • White paper finalised.

  • Currently going through PHUSE editing/publishing process.



Objectives & DeliverablesTimelines

White Paper Published

Q4 2024

Publish White Paper

Q3 2024
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3 2023