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IRB and Contracting Metrics
IRB and Contracting Metrics
IRB and Contracting Metrics
IRB and Contracting Metrics
IRB and Contracting Metrics
IRB and Contracting Metrics
IRB and Contracting Metrics
IRB and Contracting Metrics
IRB and Contracting Metrics
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IRB and Contracting Metrics

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Presented at the UC Braid Retreat: Imagine a statewide research engine of pooled resources, data, and expertise that accelerates the “translation” of academic research to direct patient benefit. …

Presented at the UC Braid Retreat: Imagine a statewide research engine of pooled resources, data, and expertise that accelerates the “translation” of academic research to direct patient benefit. That's the goal of the University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) program.

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  • 1. IRB and Contracting Metrics Subcommittees <ul><li>UC-BRAID Retreat </li></ul><ul><li>23 September 2011 </li></ul>Clinical and Translational Science Institute / CTSI at the University of California, San Francisco
  • 2. Agenda <ul><li>Mission and Team Members </li></ul><ul><li>Goals and Objectives </li></ul><ul><li>Accomplishments to date </li></ul><ul><li>Plans / Next Steps / Areas of Focus </li></ul><ul><li>Goals and Objectives for next year </li></ul>
  • 3. Mission & Goal <ul><li>Mission: To harmonize the IRB approval and contract negotiation & execution process between centers across UC, thus ensuring a high level of service with nationally competitive start-up times for investigational studies. </li></ul><ul><li>Goal: Reduce study administrative start-up times to 40-50 days. </li></ul>
  • 4. Team Members David Asmuth Associate Professor, Co-Director of CRC and CRRF Program UCD Metrics-IRB Metrics-Contracting Erick Jenkins Analyst, Health Systems Contracts UCD Metrics - Contracting       Mike Caliguri Professor of Psychiatry and Director of HRPP UCSD Metrics - IRB Tony Perez Assistant Vice Chancellor, Health Sciences Affairs UCSD Metrics - Contracting       Bishoy Anastasi Contracts Associate, Clinical Trial Contract Unit UCLA Metrics - Contracting Sharon Friend Director, Office of the Human Research Protection Program UCLA Metrics - IRB Alison Orkin Assistant Director, UCLA General Campus IRB UCLA Metrics - IRB       Bruce Morgan Assistant Vice Chancellor for Research Administration ,Office of Research UCI Metrics - Contracting Ruth Mulnard Associate Professor, Associate Director, Program in Nursing Science, College of Health Sciences UCI Metrics - IRB       John Heldens Director, UCSF Human Research Protection Program UCSF Metrics - IRB Erik Lium Assistant Vice Chancellor, UCSF Office of Innovation, Technology & Alliances UCSF Metrics-IRB, Metrics-Contracting Thierry Musy-Verdel Industry Contracts Officer, Industry Contracts Division, UCSF Office of Innovation, Technology & Alliances UCSF Metrics-IRB, Metrics-Contracting Irene Shin Associate Director, Industry Contracts Division, UCSF Office of Innovation, Technology & Alliances UCSF Metrics - Contracting Susan Shih Industry Contracts Officer, Industry Contracts Division, UCSF Office of Innovation, Technology & Alliances UCSF Metrics-IRB, Metrics-Contracting Peter St. Wecker Senior Program Manager, Clinical and Translational Science Institute UCSF Metrics-IRB, Metrics-Contracting Michael Thomas CHR Assessment Unit Manager UCSF Metrics-IRB
  • 5. Contracting Metrics <ul><li>Identifiers </li></ul><ul><ul><li>Institution, Sponsor Name, IRB Cross-Reference Number, NCT Registration Number </li></ul></ul><ul><li>Prior Terms </li></ul><ul><ul><li>UCOP Master? </li></ul></ul><ul><ul><li>Campus Master? </li></ul></ul><ul><ul><li>Existing Previous Terms? </li></ul></ul><ul><li>Study Design and CRO </li></ul><ul><ul><li>Phase of study (I, I/II, II, II/III, III, IV, early/device, other) </li></ul></ul><ul><ul><li>Multicenter? </li></ul></ul><ul><ul><li>CRO? </li></ul></ul><ul><li>Key Dates </li></ul><ul><ul><li>CDA Signature </li></ul></ul><ul><ul><li>Negotiation Start </li></ul></ul><ul><ul><li>First Comments Provided </li></ul></ul><ul><ul><li>Negotiations Finalized </li></ul></ul><ul><ul><li>Institution Execution </li></ul></ul><ul><ul><li>Sponsor Execution </li></ul></ul>
  • 6. Contracting Metrics Data Collection <ul><ul><li>“ Negotiation Start Date ” is considered the initial milestone for the contracting process. </li></ul></ul><ul><li>1-Sept-11 </li></ul><ul><li>Begin Collection </li></ul>Collect up to 50 studies <ul><li>31-Oct-11 </li></ul><ul><li>End Collection </li></ul>
  • 7. IRB Metrics Data Collection <ul><li>Metrics based on those used for CTSA IRB study. </li></ul><ul><li>Data collected on first 50 protocols approved 1-September-2010 through 30-November-2010 at each institution. </li></ul>
  • 8. Data Collection Status <ul><li>Contracting: In Process </li></ul><ul><li>IRB: Data provided by 3 out of 5 campuses </li></ul>
  • 9. Goals and Objectives for Next Year <ul><li>Complete phase I data analyses </li></ul><ul><li>Design phase II study </li></ul><ul><li>Design operational map to predict optimal phasing of administrative processes </li></ul>

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