Introduction: The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.
Methods: 807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.
In 2013, the University of California, Biomedical Research, Acceleration, Integration, and Development (UC BRAID) convened a regional network of contracting directors from the five University of California (UC) health campuses to: (i) increase collaboration, (ii) operationalize and measure common metrics as a basis for performance improvement efforts, and (iii) identify and implement best practices to maintain a competitive edge in the field of biomedical research. This article summarizes an 18-month examination of performance metrics across the five campuses, including methods for data collection and harmonization agreed upon by the UC contracting offices. Some of the most striking, and previously unmeasured, results demonstrate that master agreements are a highly effective and successful strategy for significantly shortening the average time to completion of contract terms.
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