The UI/MC SPORE Clinical Research Core (CRC) has as its primary goal to be the direct translationallink between research projects and clinical research emanating from these projects. The CRC coordinates thedevelopment of clinical trials, assists in patient accrual, manages and reports adverse events to appropriateagencies, and provides quality control on clinical trial data. The CRC also hosts the Molecular EpidemiologyResource. The CRC provides a critical link between clinical research and the specific projects and cores. TheCRC is co-directed by Brian Link, M.D., at the HCCC and Thomas M. Habermann, M.D., at the MCCC. Otherkey members of the CRC are Protocol Development Coordinators (PDC), Clinical ResearchAssociates(CRA), and Research Assistants (RA) located at both sites. The PDC functions with the PI and IRB to developand activate the clinical trial and consent form. The CRA and RA assists in recruiting patients to the trials,schedules protocol tests, and collaborates with the Biospecimens Core and the specific research projects toensure that translational research samples from patients are obtained according to protocol guidelines. TheCRA and RA arranges for data entry into the Biostatistics and Bioinformatics Core. During the previousfunding period, the CRC was very active and developed 4 clinical trials that accrued 113 patients. In addition,the Molecular Epidemiology Resource accrued 1,331 eligible patients through December 31, 2005. The CRChas worked with the Pis to develop the 4 projects in this competitive renewal and is in the process of protocoldevelopment for clinical trials outlined in Projects 1, 2, and 4. In addition, the CRC will provide ongoing supportfor the Molecular Epidemiology Resource that is being used in Project 3 and a developmental project, and isexpected to be an increasingly valuable resource as it matures. The CRC will continue to recruit patients tothe 4 trials that remain active from the first funding period and follow patients already enrolled until protocolendpoints are met. The CRC is also responsible for the clinical trials monitoring plans, which have been fullydeveloped at both sites. These monitoring plans assure that the appropriate expertise is available to reviewthe patient protocols, obtain IRB approval, and provide periodic review of ongoing protocol review to maximizepatient safety. In summary, the CRC has been an extremely valuable resource during the first funding period.It has functioned at a high level and will be a very important core in the next funding period to support theclinical trials research, translational research projects, and epidemiology projects.
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