General Clinical Research Center

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EXCEED THE SPACE PROVIDED. This competitive renewal application (RR00125) requests continued support for the Yale General Clinical Research Center (GCRC) that now includes the previously independent Children's Clinical Research Center (RR 06022) following the merge of the programs on 12/1/03. The goals of the new GCRC are to: increase services provided to investigators, competencies of research staff, the efficiency of operations, the quality of GCRC oversight and the diversity of research protocols (while maintaining traditional strengths in diabetes, metabolism, neuroscience, and psychiatry), as well as foster high quality clinical investigation and strengthen training and career development programs. Several new initiatives are proposed including Magnetic Resonance and Genomics Resource Cores and community-based nursing support. The GCRC inpatient and outpatient units and most of the GCRC staff are housed in the recently renovated 10- 5 and 10-6Units of the Yale-New Haven Hospital. Switching to a per diem method of reimbursement has reduced inpatient costs. Continued support is requested for Nursing Personnel, the Core Laboratory, Informatics, Biostatistics, Bionutrition, and the CReFF program. The commitment to protection of research subjects requires the efforts of GCRC Research Subject Advocates and improved communication and coordination with the Human Investigation Committee (HIC). The GCRC serves as a valuable resource for trainees enrolled in 23 T32 post-doctoral fellowship programs, the Investigative Medicine (K30)doctoral program, the Robert Wood Johnson Program, and the NCRR-supported K12 program, as well as K23 and K24 awardees. Finally, Yale has in place a large body of clinical research that requires and is enhanced by GCRC support. The 118 protocols described in this application come from a broad range of clinical investigators with diverse interests that involve research subjects from premature infants to the elderly. This GCRC- based research is supported by peer reviewed grants that total ~$33 million of which ~94%are NIH funded. The central role of GCRC clinical research programs at the medical center is reflected by the strong and tangible commitments that the new Dean of the School of Medicine and Yale-New Haven Hospital leadership have made to our newly merged unit.