Versions Compared

Old Version 51

changes.mady.by.user Kerry Robson

Saved on

compared with

New Version Current

changes.mady.by.user Alex Pearce

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


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 ()Q1 2023 
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 

nicky@phuse.global 


Boehringer Ingelheim 

Status
colourBlue
titleCurrent Status
Q3/4 2022

  • Aiming to complete analysis by Q1 2023
  • Draft white paper by early Q2 2023
Project MembersOrganisation
Aatiya ZaidiGilead
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
Susan Takas Johnson & Johnson
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