A multisite study of performance drivers among institutional review boards.

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. RESULTS: High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times. CONCLUSIONS: Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

Collaboration in Action: Measuring and Improving Contracting Performance in the University of California Contracting Network.

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. Interestingly, clinical research organizations (CROs) significantly increase the time required to negotiate a contract. Results also point to the intra- and inter-organizational dependencies affecting time to contract execution. Systematic and transparent data collection among UC stakeholders is necessary to continue improvements to the system. However, data collection is only one component of the larger need to develop shared technology both within and between institutions. This study demonstrates that collaboration and sharing of contract terms is an effective way to reduce study activation time, but the greatest improvements will be driven by the sharing of data and technology tools.