CTSA Administrative Supplement QA/QC

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The Buffalo Translational Consortium (BTC), which includes the University at Buffalo (UB) health sciences schools, the major healthcare institutions in our region, four key research institutes and five influential community partners, have embarked on a comprehensive strategic plan to build a strong foundation for clinical and translational research in response to our community needs. Buffalo is the second most populous city in New York State and has a rich cultural history. The proportion of underrepresented minorities in Buffalo (50%) parallels that projected for the US in 2050, making Buffalo a microcosm of what the US will look like in 30 years. A similar proportion of our population experiences health disparities. The vision for our CTSA hub is to perform innovative research across the translational spectrum to improve the health of our community and the nation. Achieving these ambitious goals is a complex process that requires the participation of personnel with a wide range of expertise. The complexity of clinical and translational science and the national regulatory climate have led to an increasing importance of regulatory and research administrative expertise to streamline and accelerate moving discoveries through the translational pipeline toward improving health. As a result, several activities supported by our CTSA require formal NCATS prior approval. Providing clear and accurate documentation for prior approval is critical in eliminating delays in the start-up of research projects, thus bypassing an important bottleneck in advancing the testing and implementation of translational discoveries. The overall goal of this Supplement is to establish processes and procedures to provide accurate and high quality data and documents to NCATS for prior approval to streamline the start-up and conduct of research projects. Support for a Quality Assurance Specialist who will participate in the management of the process of providing submissions to NCATS and perform quality reviews of documents and material submitted is requested in this proposal. To accomplish these goals, we propose the following Aims. We will establish a Quality Assurance Specialist position to provide quality reviews and expert assistance to research teams in preparing CTSA-related submissions to NCATS for prior approval (Aim 1). The Quality Assurance Specialist will work with our Workforce Development Core to provide education and training to research teams in grants management, regulatory matters and CT.gov submissions to ensure compliance and reduce delays in implementation of research projects (Aim 2). Finally, we will monitor the effectiveness of our hub processes in providing accurate, high quality submissions to NCATS; CT.gov compliance; and education and training programs for research teams (Aim 3). This new system supported by a Quality Assurance Specialist will substantially improve the quality and timeliness of our submissions to NCATS for prior approvals, streamline the start-up and conduct of research projects, and provide important education and training to research teams in our hub.