Support for QA/QC for Prior Approval Process

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Abstract of overall Duke CTSA grant: The mission of the Duke Clinical and Translational Science Institute is to catalyze the translation of scientific discoveries into population health benefits through collaborative research. With previous Clinical and Translational Science Award (CTSA) funding, we have successfully developed infrastructure and provided resources to support investigators across the clinical and translational scientific and workforce spectrums. Our achievements have facilitated high-impact discoveries, increased research efficiency, and nurtured a more capable and diverse workforce. We have also ignited a new era of collaborative science at Duke. Several new transdisciplinary programs have been launched, connecting trainees and faculty from our Schools of Medicine, Nursing, Engineering, Business, and Arts and Sciences to enhance translation. In the next phase, Duke proposes to capitalize on new opportunities with three broad initiatives. First, we will optimize clinical and translational science national networks’ methods and processes. Building on Duke’s leading experience coordinating multi-center clinical trials including its national Duke-Vanderbilt NCATS Trial Innovation Center, we will develop methods to optimize ‘local hub,’ ‘hub-to-network’, and ‘network-to-network’ processes for the NCATS Trial Innovation Network. We will also help investigators leverage a number of additional NIH network resources and provide methods to disseminate best practices throughout the CTSA network. Second, we will deepen, nurture, and extend stakeholder collaborations. We will strengthen existing partnerships and foster new ones with stakeholders at both the institutional and investigator levels. Partnerships and programs will expand the breadth and transparency of CTSI activities. We will also support investigators’ greater engagement with a broad range of patients, community groups, clinicians, health care systems, industry, venture capitalists, payers, policy makers, and others. Third, we will catalyze further science integration at Duke. An invigorated professional workforce will facilitate major transdisciplinary science initiatives. A new University-wide coordination infrastructure will further amplify collaboration and bridge science siloes. We will also support teams by improving their skills in team science, studying team processes, and by promoting the recognition of team contributions at our institution. Collectively, these activities will amplify the innovation and impact of our research nationally, regionally, and locally. We will measure outcomes that reflect improvement in the translation of discoveries, use of national best practices, institutional and investigator teamwork, research transparency, and community trust. We will share all best practices with the CTSA network. We believe our achievements will meaningfully enhance the impact of clinical and translational science on health across the United States.