UCC--RCRII CENTER

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A proposal for the establishment of a clinical research center that creates an infrastructure to effectively promote clinical research at UCC, is presented. Three distinct components are described: a core facility, a faculty development program and clinical research priority areas. The core facility will have adequate space for the conduct of clinical research. It will also have computer facilities for data entry and statistical analysis. Support personnel such as an epidemiologist,statistician,nurses,data entry spec., research technicians and secretary, necessary to carry out clinical research are also included. The faculty development component is designed to increase the clinical research capability of the institution through the recruitment of an accomplished clinical researcher and capacitation of presently existing faculty. Priority areas where clinical research development will be emphasized are described. These were chosen on the basis of present research interests, capabilities and patient availability. Four pilot projects are submitted with this application. In the Health Care Evaluation and Delivery priority area two projects are submitted. A supportive model for health prevention in the elderly aims to improve the quality of life and health outcomes of geriatric patients. The second project aims to create a registry of social, epidemiological and medical data of a well defined population in one of the municipalities of Puerto Rico. In the Chronic Diseases priority area one project is submitted. It aims to study the clinical and immunogenetic characteristics of Puerto Rican patients with systemic lupus erythematosus. Finally, a trial to evaluate immunological and virological markers of HIV-1 infection disease progression in a Hispanic population is submitted. This trial is part of the Chronic Diseases priority area. An administrative structure that will actively promote development of clinical research, be watchful of the rights of human subjects studied and of scientific integrity is described. The administrative structure is composed of a PI, PD and several committees that oversee the development and functioning of the Program.