Admin-Core-001

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The CCTSI was created in 2008 at CU-D as an institute with the authority and broad reach to forge relationships within the CU system and with outside partners, communities, affiliated hospitals, and industry. The Director/PI of the CCTSI, Dr. Sokol has programmatic authority and autonomy to implement the programs and functions of the Institute, manage the space assigned to the CCTSI, and hire and fire personnel within the Institute. Collaboration has been obtained from CU-D, CU-B and CSU leadership, the Deans of each health profession school, CEOs of each Affiliate Hospital and Health Care Organization, community organizations,, corporate leaders, officials at each campus, and most importantly, the faculty, investigators and trainees. The organizational structure for the CCTSI provides an infrastructure to support a broad range of T0.5 to T4 research activities across the partnering institutions and as the foundation for training and developing the next generation of clinical and translational workforce. The over-arching goal is to provide a robust and supportive governance structure and research environment to enable and ensure high quality, highly efficient, cost-effective and compliant research to flourish at our institutions. An outstanding leadership group who have worked together for a number of year is proposed. There is close integration among all functions, with themes of community engagement, use of informatics and technology, collaboration and communication permeating throughout the entire CCTSI organization, as will be demonstrated in the individual sections of this proposal. The Specific Aims are to: Aim 1) Provide an integrated Organizational Governance Structure that engages participating institutions and constituencies to promote the vision of the CCTSI; Aim 2. Develop processes for Evaluation and Continuous Improvement that ensure responsive tracking of metrics, assessment and evaluation; Aim 3. Promote a systemwide approach to ensure the highest Quality, Efficiency and Safety in the entire clinical study life cycle, and Aim 4. Disseminate successful solutions to translational barriers locally and throughout the CTSA Consortium. Continuous quality and process improvement will be emphasized, communication and collaboration among the partner institutions will be promoted and valued. In collaboration with our Evaluation Core, Common Metrics and local metrics will be established and reported to monitor progress and evaluate potential areas of focus for the CCTSI quality and process improvement team. CCTSI will work closely with the Clinical Research Administration Office (CRAO) at CU-D to ensure study quality, participant safety and operational efficiencies during the entire study life cycle. Our Dissemination Core will perform consultations and provide educational materials to bring best practices in dissemination of medical advances to our communities.