Utah Trial Innovation Center

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Project Summary The NIH established the Clinical and Translational Science Award (CTSA) program in 2006 to enhance trans- lation of biomedical discoveries into therapeutic, diagnostic and preventive interventions to benefit patients and communities. In 2011, the CTSA Program became part of the National Center for Advancing Translational Sci- ences (NCATS). Assessment by the Institute of Medicine (IOM) in 2013, and recommendations from the NCATS Advisory Council Working Group in May 2014, have contributed to the vision that the consortium of CTSA Pro- grams should evolve into a collaborative national network to enable more efficient planning and implementation of high-quality multi-center research. NCATS began this evolution by requiring each CTSA Hub to actively partic- ipate in a developing national CTSA network (RFA-TR-14-009). NCATS is continuing the process by establishing Trial Innovation Centers (TICs) to accelerate implementation of multi-center studies by adding innovative network capacity to the existing strengths at the CTSA Hubs. The University of Utah proposes to be a TIC for the CTSA Network, with a focus on pediatrics, but capability across the lifespan. This proposal has three specific aims. Specific Aim 1. Provide immediate communication infrastructure for the TICs, RICs, NCATS, and CTSA investigators, and immediate capacity for NCATS to accept and assign trials on day 1, using our existing IT infrastructure, protocol development teams, functional reliance agreements and umbrella study contracts, central IRB procedures, budget templates, and capitation payment systems. Specific Aim 2. In the first six months, collaborate with the other TICs and the CTSA Network to standardize reliance agreement and contract language, consent templates, operating procedures, shared IT systems, innovative budgeting procedures, cIRB procedures, and performance measurement; and, subsequently implement a coordinated plan for securing agreements with all CTSA Hubs and their affiliates. Specific Aim 3. Using well-defined metrics to evaluate all trials supported by the three TICs and the two RICs, compare different strategies of trial planning, organization and implementation to identify and disseminate innovative ways to increase the quality and efficiency of multi-site clinical research. With our experience coordinating diverse multi-center trials across a broad range of diseases, the Trial Inno- vation Center at the University of Utah will provide immediate access to proven resources (electronic communica- tions, cIRB, protocol assistance, streamlined contracting and budgeting expertise) to accelerate the evolution of the CTSA Network. We will share our existing resources, learning about and adopting better resources from other Network participants. We are excited to have the opportunity to help realize the potential of the CTSA program as a national laboratory for studying, understanding, and improving multi-site translational research.