Tufts Clinical and Translational Science Institute (Pilot Supplement)

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SUMMARY The proposed project will bring together Tufts Clinical and Translational Science Institute (CTSI) faculty and staff to address translational roadblocks associated with managing National Center for Advancing Translational Science (NCATS) Prior Approval requests. Tufts CTSI will build on our long-standing Research Process Improvement (RPI) and Pilot Studies programs to develop new tools, strategies, quality improvement metrics, and to deploy dedicated personnel to perform quality reviews of hub Prior Approval request submissions to NCATS and the eRA Human Subjects System. We will also create tools and processes to more effectively collaborate with investigators on preparing Prior Approval packages to request approval for CTSA-funded research and to liaise with institutional and NCATS representatives to manage Prior Approval-related processes. Relevant Prior Approval requests include, but are not limited to: 1) changes in key personnel, 2) addition of a foreign component, 3) request to carryover funds, and 4) requests to conduct animal- and human-subjects research by all new Mentored Clinical Research Scholar (KL2) projects and certain Pilot Studies projects. The preliminary focus of our efforts will be an increased monitoring of Prior Approval request packages for CTSA-funded animal- and human-subjects research projects, which have been particularly challenging and time-consuming for our hub. To achieve these goals, we propose expanding the roles and responsibilities of RPI and Pilot Studies program personnel to develop tools and processes for preparing Prior Approval packages, perform enhanced quality assurance/quality control (QA/QC) reviews of packages prior to submission, and to share evidence-based best practices for submission of NCATS Prior Approval requests with the goal of improving the quality, consistency, and efficiency of NCATS Prior Approval requests. With Tufts CTSI's experience leading national quality and process improvement initiatives, we anticipate the proposed work will have a significant impact on improving NCATS Prior Approval requests locally at our hub, but also nationally as we contribute resources and provide trainings to the CTSA Consortium.