EXCEED THE SPACEPROVIDED.This competitive renewal application (RR00125) requests continued support for the Yale General Clinical ResearchCenter (GCRC) that now includes the previously independent Children's Clinical Research Center (RR 06022) followingthe 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 researchprotocols (while maintaining traditional strengths in diabetes, metabolism, neuroscience, and psychiatry), as well asfoster high quality clinical investigation and strengthen training and career development programs. Several newinitiatives are proposed including Magnetic Resonance and Genomics Resource Cores and community-based nursingsupport. 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 reducedinpatient 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 GCRCResearch 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, theInvestigative Medicine (K30)doctoral program, the Robert Wood Johnson Program, and the NCRR-supported K12program, as well as K23 and K24 awardees. Finally, Yale has in place a large body of clinical research that requiresand is enhanced by GCRC support. The 118 protocols described in this application come from a broad range of clinicalinvestigators 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 centralrole of GCRC clinical research programs at the medical center is reflected by the strong and tangible commitments thatthe new Dean of the School of Medicine and Yale-New Haven Hospital leadership have made to our newly merged unit.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000125-42
Application #
6963130
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Program Officer
Merchant, Carol
Project Start
1997-04-01
Project End
2006-09-29
Budget Start
2006-03-06
Budget End
2006-09-29
Support Year
42
Fiscal Year
2006
Total Cost
$3,372,063
Indirect Cost
Name
Yale University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
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Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Arslanian, Silva; El Ghormli, Laure; Bacha, Fida et al. (2017) Adiponectin, Insulin Sensitivity, ?-Cell Function, and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care 40:85-93
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Kelsey, Megan M; Geffner, Mitchell E; Guandalini, Cynthia et al. (2016) Presentation and effectiveness of early treatment of type 2 diabetes in youth: lessons from the TODAY study. Pediatr Diabetes 17:212-21

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