CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

该子项目是对CTSA供资的百分比的估计， 用于广泛的研究领域（艾滋病研究，儿科研究，或 临床试验）。 列出的总成本仅为CTSA金额的估算 用于该研究领域的基础设施，而不是直接提供的资金 向子项目或子项目工作人员提供NCRR补助金。 转化和临床研究是生物医学研究的最高荣誉，但这项研究的基础设施没有得到适当的重视。西储大学/克利夫兰诊所CTSA（CTSA）我们将协调与凯斯西储大学及其三家附属医院克利夫兰诊所、MetroHealth医疗中心和大学医院凯斯医疗中心的临床研究相关的现有资源，包括三个现有的GGRC设施，一个成功的多学科机构K12计划，目前存在于孤岛中的大量技术和统计核心设施，以及我们著名的基于实践的研究网络。此外，我们将创造新的资源，包括社区合作资源，一个新的协调生物信息学基础设施，一个新的M. D-Ph. D。临床研究计划，并协调生物伦理学和监管支持方面的资源。作为临床研究的学术之家，由CTSA PI和Case医学院临时院长指导的临床研究中心将为临床研究者提供必要的职业发展支持。当它完全运作时，CTSA将提供研究参与者资源，这些资源涵盖了对需要学术医疗中心资源的技术密集型研究的支持范围，以当地实践，克利夫兰社区本身。社区，包括组织和个人，将参与关于以患者为基础的研究的对话。这些参与者资源将得到技术核心、方法学发展和生物医学信息学基础设施的支持。渗透到整个企业是一个教育计划，由CTSA Co-Pi指导，不仅充分利用我们的机构教育实力，而且还利用CTSA临床研究资源。CTSA资源将通过临床研究会议在线或亲自访问，这将确保统计和设计专家，伦理学家和监管专家以及项目所需的任何其他专业知识对提案的前瞻性投入。在CTSA合作伙伴之间强有力合作的背景和记录下，精简业务和协调资源将导致有效利用稀缺资源，并最大限度地支持克利夫兰市的临床研究，最终将使我们的公民和所有美国人的健康受益。

This subproject represents an estimate of the percentage of the CTSA funding that is being utilized for a broad area of research (AIDS research, pediatric research, or clinical trials). The Total Cost listed is only an estimate of the amount of CTSA infrastructure going towards this area of research, not direct funding provided by the NCRR grant to the subproject or subproject staff. Translational and clinical research are the crowning glories of biomedical research, but the infrastructure for this research has not received appropriate attention. In the Case Western Reserve University/Cleveland Clinic CTSA (the CTSA) we will coordinate existing resources relevant to clinical research at Case Western Reserve University and three of its hospital affiliates, the Cleveland Clinic, MetroHealth Medical Center, and University Hospitals Case Medical Center, including three existing GGRC facilities, a successful multidisciplinary institutional K12 program, substantial technological and statistical core facilities that currently exist in silos, and our famous practice-based research networks. In addition, we will create new resources, including community partnership resources, a new coordinated bioinformatics infrastructure, a new M.D-Ph.D. program in clinical research, and coordinated resources in bioethics and regulatory support. An academic home for clinical research, the Center for Clinical Investigation, directed by the CTSA PI and Interim Dean of the Case School of Medicine, will provide the career development support necessary for clinical investigators. When it is fully operational, the CTSA will offer research participant resources that span the range of support for technology-intensive studies that require the resource of the Academic Medical Centers, to local practices, to the Cleveland community itself. The community, both organizations and individuals, will be engaged in a dialogue about patient-based research. These participant resources will be supported by technologic cores, methodologic development, and an infrastructure of biomedical informatics. Permeating the entire enterprise is an educational program, directed by the CTSA Co-Pi, that takes full advantage of not only our institutional educational prowess, but also the CTSA clinical research resources. CTSA resources will be easily accessed either online or in person through a Clinical Research Concierge, which will assure prospective input into proposals by statistics and design experts, ethicists:and regulatory experts, and any other expertise that the project requires. Streamlining of operations and coordination of resources, set against a backdrop and track record of strong cooperation among the CTSA partners, will lead to efficient use of scarce resources and maximal support of clinical research in the city of Cleveland, which ultimately will benefit our citizens and the health of all Americans.