Versions Compared

Old Version 58

changes.mady.by.user Former user

Saved on

compared with

New Version Current

changes.mady.by.user Nicola Newton

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

sandra.vanpeltnguyen@pfizer.com

Nicola Newton, PHUSE Project Assistantkatie@phuse.global

nicky@phuse.global 


Status
colourBlue
titleCurrent Status
Q3 2024

  • White paper finalised.

  • Currently going through PHUSE editing/publishing process.



Objectives & DeliverablesTimelines
Draft Publish White Paper ready to go through PHUSE review processQ2 Q4 2023 
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3 2023
Status
colourBlue
titleCurrent Status
Q1 2023

Drafting white paper and continuing work that was done on PHUSE/FDA CSS Poster and US Connect Presentation

Project MembersOrganisationAatiya ZaidiGileadAimee BasileSurface OncologyBrook (Amanda) HinksonMerckCarlo RadovskyNurocorCathy YangRocheGayathri MahadevanAstrazenecaGina WoodeClinical SolutionsJennifer JarvisEli LillyJennifer ManziPinnacle 21 Junying ZhangGileadKapil AnandParexelKishore Pothuri Vita Data SciencesLigia Kilinski CevascoJazz PharmaceuticalsMatt Baldwin AmgenNicholas Pemble Johnson & JohnsonParisa Osivand PourIndustryPriyanka Pollarine BiogenRamaiah MuvvalaInductive QuotientRanvir SinghLabcorpRie IchihashiSanofiRony YeEBSISathesh AvvaruPPDSusan Takas Johnson & JohnsonTingting Tian RegeneronTitania Dumas-RobersonUnither PharmaceuticalsTodd BazinBiogenTorsten PetschingBoehringer Ingelheim