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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.



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

sandra.vanpeltnguyen@pfizer.com

Nicola Newton (, PHUSE Project Assistant)

nicky@phuse.global 


Status
colourBlue
titleCurrent Status
Q1 2024

  •  Finishing draft white paper and sending for PHUSE/public reviews



Draft ready to go through PHUSE review processQ2 2023
Objectives & DeliverablesTimelines
Publish White Paper
Q4 2023 
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3
Status
colourBlue
titleCurrent Status
Q2 2023
  • Ongoing work with drafting the White Paper
  • Continuing work that was done on PHUSE/FDA CSS poster and US Connect presentation
Project MembersOrganisationAatiya ZaidiGileadAimee BasileSurface OncologyBrook (Amanda) HinksonMerckCarlo RadovskyNurocorCathy YangRocheGayathri MahadevanAstrazenecaJennifer JarvisEli LillyJennifer ManziPinnacle 21 Junying ZhangGileadKapil AnandParexelKishore Pothuri Vita Data SciencesLigia Kilinski CevascoJazz PharmaceuticalsMatt Baldwin AmgenMonika Buda AstrazenecaNicholas Pemble Johnson & JohnsonParisa Osivand PourIndustryPriyanka Pollarine BiogenRamaiah MuvvalaInductive QuotientRanvir SinghLabcorpRie IchihashiSanofiRony YeEBSISathesh AvvaruPPDSusan Takas Johnson & JohnsonTingting Tian MerckTitania Dumas-RobersonUnither PharmaceuticalsTodd BazinBiogenTorsten PetschingBoehringer Ingelheim