Systems approach to assessing and improving local human research Institutional Review Board performance.

OBJECTIVE: To quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations. METHODS: Over 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies. RESULTS: Staffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process. CONCLUSIONS: Understanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.

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.