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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.



Timelines
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

Objectives & Deliverables


Boehringer Ingelheim 
Draft White Paper ready to go through PHUSE review processQ2 2023 
Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedbackQ3 2023

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 MembersOrganisation
Aatiya ZaidiGilead
Aimee BasileSurface Oncology
Brook (Amanda) HinksonMerck
Carlo RadovskyNurocor
Cathy YangRoche
Gayathri MahadevanAstrazeneca
Jennifer JarvisEli Lilly
Jennifer ManziPinnacle 21 
Junying ZhangGilead
Kapil AnandParexel
Kishore Pothuri Vita Data Sciences
Ligia Kilinski CevascoJazz Pharmaceuticals
Matt Baldwin Amgen
Monika Buda Astrazeneca
Nicholas Pemble Johnson & Johnson
Parisa Osivand PourIndustry
Priyanka Pollarine Biogen
Ramaiah MuvvalaInductive Quotient
Ranvir SinghLabcorp
Rie IchihashiSanofi
Rony YeEBSI
Sathesh AvvaruPPD
Susan Takas Johnson & Johnson
Tingting Tian Merck
Titania Dumas-RobersonUnither Pharmaceuticals
Todd BazinBiogen
Torsten Petsching



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