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.
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