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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

nicky@phuse.global

 


Q12022Boehringer Ingelheim 
Objectives & DeliverablesTimelines

Build survey

Q12022

Distribute survey to public Q12022
Summarise results in a White Paper Q2/32022
Plan to submit poster for CSSQ32022

Status
colourBlue
titleCurrent Status

  • Survey was released to the public. 
  • Started drafting introductory sections of White Paper.
Project MembersOrganisation
Aimee BasileSurface Oncology
Brook (Amanda) HinksonMerck
Carlo RadovskyImmanant
Cathy YangRoche
Gayathri MahadevanCytel
Gina WoodeClinical Solutions
Jennifer JarvisEli Lilly
Junying ZhangGilead
Kapil AnandParexel
Ligia Kilinski CevascoJazz Pharmaceuticals
Matt Baldwin Amgen
Parisa Osivand PourIndustry
Patrick GenynJanssen Research and Development
Ranvir SinghLabcorp
Rie IchihashiSanofi
Rony YeEBSI
Sathesh AvvaruPPD
Tingting Tian Regeneron
Titania Dumas-RobersonUnither Pharmaceuticals
Todd BazinBiogen
Torsten Petsching

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