Southern California Clinical and Translational Science Institute

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ABSTRACT The Southern California Clinical and Translational Science Institute (SC CTSI) is committed to ensuring safe, efficient, and high-quality research to improve health. As part of ongoing operational review within the SC CTSI, we have identified the process of obtaining NCATS approval to conduct research involving human subjects as an important opportunity for enhancing efficiency. Assessment of this process has revealed that lack of knowledge on the part of investigators and lack of a single individual dedicated to this specialized and labor-intensive process contribute to delays, which slow translational research overall. We propose to hire a new Quality Assurance (QA) Specialist who will specialize in the human subjects' prior approval process and associated training and facilitation. The Specialist will (a) implement and maintain a streamlined quality assurance and control program that is aligned with institutional and federal regulatory processes for human subject protections and (b) engage in regular training to increase local capacity for preparing high-quality submissions. The overarching goal will be to enhance efficiency and quality through consultations, process improvement, communication, and training. The immediate outcomes will be shorter activation times for clinical studies, a better informed and more efficient CTR workforce, and reduced administrative burdens on other SC CTSI staff, the IRBs and NCATS. The long-term impacts will be more trials completed successfully and faster, as well better administrative integration of the SC CTSI with our IRBs, NCATS and other hubs. Innovative approaches such as use in this setting of the Kaizen method and a scalable project management tool, Monday.com will be shared with the NCATS QA/QC group to help improve efficiency and quality across the CTSA network.