February 12, 2024

Data Governance Committee Meeting 2024.2.12

Data Goverannce Committee Meeting

February 12, 2023

Attendees: Carol Levy, Daniel DeSalvo, Ann Mungmode, Osagie Ebekozien, Holly Hardison, David Hansen, Isabel Reckson, Ruth Weinstock, Todd Alonso, Ryan McDonough, Marina Basina, Grace Nelson

Agenda:

• Welcome
• Updates on Sponsored Projects
• Process review -ensuring reliable systems
• Reasons to consider becoming a DGC Co-Chair

Projects Updates:

• As of Feb 2024, 9 partners on 20 projects
• Vertex (on track)
  • Evaluate total daily insulin use between 2-25 years old
• ADA (on track)
  • Know Diabetes by Heart, 3 adults outside of T1DX
• Abbott (on track)
  • Establish large T2D data set, evaluate T2D data for benchmarking
  • Grady, BMC, Pittsburgh
• Tanden (on track)
  • Analyze technologies
• JDRF/Sanofi (expansion update)
  • Implement the model improvement for PDSA cycles
  • Establish data elements for screening and patient outcomes
  • UF and Rady Childrens, expanding to 5 additional ped centers
• Eli Lilly (new project)
  • Conduct qualitative research interview
• Lexicon (contract pending)
  • Understand association between DKA and kidney disease

Data Governance Process Review:

• Ensuring reliability yin Data Governance
  • Analysis results
    • T1DX owns the raw data not the sponsor/requestor
  • FDA submission
    • If a sponsor/requestor wants to submit results to the FDA when does GDC get involved?
    • Data quality
      • If data does not meet our standards for quality, we remove it from the analysis
      • T1DX-QI is big enough that if 2-3 centers are experiencing data quality at the time of the analysis, we still have a robust enough population to pull results from
    • Requests from National organizations
      • If the CDC/NIH/HHS reach out to the T1DX for data, does their request supersede DGC policies?
    • Committee recommendations for updates to the DGC Charter:
      • DG to review FDA and Analysis results to be clear on how the data is analyzed and how the data is shared publicly; recommendation to have a quorum to review and approve
      • CDC/NIH/HHS – less time sensitive so communicate with centers to ensure quality and accuracy of analysis; minimally requires co-chair review

Co-Chair Nominations:

• Co-Chair Nominations due March 15^th
• New Co-chair terms will begin June 1
  • Use this link to view committees and charters
  • Use this link to submit a nomination
• Seat at the table, contribute as a subject matter expert
• Leadership on a national committee
• Co-lead with peers across populations (peds and adult)

Link to Recording: https://us02web.zoom.us/rec/share/AvvH81T-ORvevwRXxTtx4lziZwIK1MCnU5czTidiJG78rJaLM-nL_9t2_jXIDMCA.w7W00A6lpecKmF50

Passcode: JyFmlV0=

Next Meeting: Monday April 15^th 10-11am EST