Core-005

密歇根州临床与健康研究所（MICHR）建议建立一个新的机构， 基础设施-密歇根大学（U-M）临床研究网络-由跨部门 临床研究服务单位，最初专注于所有高质量临床试验的有效进行 阶段。MICHR将在密歇根大学的所有七所健康科学学院领导这一倡议。系统和 这一转型的全面性将使我们能够嵌入和测试许多新的流程， 提高质量，降低特殊人群参与的障碍，并加速整个 平移连续统我们的长期目标是开发、展示和传播最佳实践， 扩大中心研究能力。为了实现这一目标，我们将有系统地实施一系列 我们假设将提高我们当地研究的质量和效率的过程和程序 基础设施，使我们能够实现跨多个研究和社区的连接和集成 单位我们将通过以下具体目标来实现这些目标：1）改进枢纽研究 通过在企业范围内实施跨部门的临床研究服务，提高密歇根大学的能力 单位基础设施; 2）通过改善知情的儿童临床转化研究减少障碍 同意并加强当地和国家儿科人群的临床试验基础设施; 3） 通过整合和推进老年医学，减少老年人临床转化研究的障碍 研究基础设施。我们希望通过全面的研究来扩大中心的研究能力。 以临床试验企业为初始重点的转型将实现更高的试验质量和效率， 同时建立一个平台，使我们能够改善密歇根大学的所有临床和转化研究。过程 将仔细跟踪变化，使我们能够确定最佳做法和经验教训， 在CTSA网络及其他地方传播。此外，我们希望增加参与 在临床和转化研究中对特殊人群的研究。

The Michigan Institute for Clinical & Health Research (MICHR) proposes the development of a new institutional infrastructure—the University of Michigan (U-M) Clinical Research Network—comprised of trans-departmental Clinical Research Service Units that focus initially on the efficient conduct of high-quality clinical trials of all phases. MICHR will lead this initiative across all seven health science schools of U-M. The systematic and comprehensive nature of this transformation will enable us to embed and test many new processes aimed at enhancing quality, lowering barriers to engaging special populations, and accelerating discoveries across the translational continuum. Our long-term goal is to develop, demonstrate, and disseminate best practices for expanding hub research capacity. In order to fulfill this objective, we will systematically implement a series of processes and procedures that we hypothesize will enhance the quality and efficiency of our local research infrastructure, allowing us to achieve connectivity and integration across multiple research and community units. We will achieve these objectives by pursuing the following specific aims: 1) Improve the hub research capacity of U-M through the enterprise-wide implementation of a trans-departmental Clinical Research Service Unit infrastructure; 2) Reduce the barriers to clinical-translational research in children by improving informed consent and enhancing both local and national clinical trial infrastructure for the pediatric population; 3) Reduce the barriers to clinical-translational research with older adults by integrating and advancing geriatric research infrastructure. We expect that expanding hub research capacity through a comprehensive transformation with an initial focus on the clinical trial enterprise will achieve greater trial quality and efficiency, while establishing a platform that will allow us to improve all clinical and translational research at U-M. Process changes will be tracked carefully, enabling us to identify best practices and lessons learned that could be disseminated throughout the CTSA network and beyond. Furthermore, we expect to increase the participation of special populations across the lifespan in clinical and translational research.