Utah Trial Innovation Center

项目摘要 美国国立卫生研究院于2006年设立了临床和翻译科学奖(CTSA)计划，以促进 将生物医学发现转化为治疗、诊断和预防干预措施，使fi患者和 社区。2011年，CTSA计划成为国家翻译科学促进中心的一部分。 恩斯(NCATS)。医学研究所(IOM)2013年的评估和NCATS的建议 咨询委员会工作组于2014年5月成立，推动了CTSA Pro- fi应该演变为一个协作的国家网络，以实现更有效的规划和实施 高质量的多中心研究。NCATS通过要求每个CTSA集线器主动分配- 正在发展中的国家CTSA网络中的IPATE(RFA-TR-14-009)。NCATS正在继续这一进程，建立 试验创新中心(TICS)通过增加创新网络来加速实施多中心研究 CTSA枢纽的现有能力。 犹他大学提议成为CTSA网络的TIC，专注于儿科，但能力 在整个生命周期内。这项建议有三个具体的fic目标。SPECIfic目标1.提供即时通信 TICS、RICS、NCATS和CTSA调查人员的基础设施，以及NCATS接受的即时能力 并在第一天使用我们现有的IT基础设施、协议开发团队、功能依赖 协议和总括研究合同、中央IRB程序、预算模板和按人头计算的付款 系统。Speciific Aim 2.在fi的前六个月，与其他TIC和CTSA网络合作，以 标准化信赖协议和合同语言、同意模板、操作程序、共享IT 系统、创新的预算编制程序、CIRB程序和业绩衡量；以及随后 实施协调计划，以确保与所有ctsa枢纽及其affi分支机构达成协议。SPECIfic目标 3.使用Well-defiNed度量对三个TIC和两个RIC支持的所有试验进行评估，比较 试验规划、组织和实施的不同战略，以确定和传播创新方法 提高多点临床研究的质量和效率。fi。 凭借我们协调各种疾病的不同多中心试验的经验，INNO- 犹他大学的创新中心将提供对经过验证的资源的即时访问(电子通信- 技术、CIRB、礼宾援助、简化的合同和预算专业知识)，以加快发展 CTSA网络。我们将分享我们现有的资源，学习和采用其他公司更好的资源 网络参与者。我们很高兴有机会帮助实现CTSA计划的潜力 作为研究、理解和改进多站点翻译研究的国家实验室。

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.