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
- Analysis results
Co-Chair Nominations:
- Co-Chair Nominations due March 15th
- New Co-chair terms will begin June 1
- 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 15th 10-11am EST
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