Core-006

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Network Capacity: The CCTSI will develop a CTSA Trial Innovation Network Hub Liaison Team to closely coordinate with the national NCATS Trial Innovation Centers (TICs) and Recruitment Innovation Centers (RICs) within the Trial Innovation Network (TIN). Providing the foundation for this network expansion, the CCTSI has already played a key role in the many local initiatives to enable the institution’s full and robust involvement in the TIN (e.g., ACTA and SMART IRB sign-ons). The Clinical Research Administration Office (CRAO) was created in January of 2016 to bring together in one location the administrative, contracting and regulatory components for clinical trials from across the Anschutz Medical Campus, essential for expansion of our network capacity. This office is well connected to the IRB, the Office of Grants and Contracts, research compliance and other critical institutional bodies necessary to support clinical research, as well as the CCTSI BERD and Informatics Cores. The Hub Liaison Team will build on this centralized research effort to facilitate multi-center trials from the TIN at our center. CRAO also positions the institution to better monitor progress of clinical trial development, start-up, implementation and close-out and to advance efficiencies into these processes. The CCTSI-supported Study Monitoring Committee complements these efforts by providing oversight over ongoing studies and will work with the Hub Team to maintain appropriate levels of accrual support for TIN multi-center trials. In addition, our robust CCTSI clinical research unit network (CTRCs) provides the facilities and personnel needed to conduct these trials. The establishment of the Hub Liaison Team will now provide a local resource to greatly facilitate the performance of NIH-funded (and other) multi-site trials at our institutions through 3 Specific Aims: Aim 1 will fully establish and optimize the TIN Hub Liaison Team within the CCTSI, developing the infrastructure and personnel to provide ongoing support to TIN studies and local development of multi-site clinical trials. Aim 2: The TIN Hub Liaison Team will develop the processes and procedures to adequately facilitate the operationalizing of multi-center trials within the CCTSI, which originate at other sites within the TIN. Aim 3: The Hub Liaison Team will support the development and advancement of locally-generated multi-site clinical trials to the TIN. The CRAO provides the foundation that the TIN Hub Liaison Team will build upon, ensuring access to a well-coordinated institutional clinical research administration. The Hub Team will connect and support local investigators in coordination with the TIN resources in this context, allowing for the facilitation of multi-center clinical trials, thus expanding our network capacity.