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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.



(Merk)  ()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

Survey

Q1 2022

Summarise survey results in a White Paper Q2/3 2022
Poster at PHUSE/FDA CSSQ3 2022 
Publish White Paper Q1 2023 

nicky@phuse.global 


Q2/3 2022Boehringer Ingelheim 

Status
colourBlue
titleCurrent Status

  • Starting to draft White Paper
  • Working on a poster for PHUSE/ FDA CSS 2022
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
Nicholas Pemble Johnson & Johnson
Parisa Osivand PourIndustry
Ramaiah MuvvalaInductive Quotient
Ranvir SinghLabcorp
Rie IchihashiSanofi
Rony YeEBSI
Sathesh AvvaruPPD
Tingting Tian Regeneron
Titania Dumas-RobersonUnither Pharmaceuticals
Todd BazinBiogen
Torsten Petsching

Q4 2024

  • White paper published.



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