The Clinical Research Core will provide a platform and infrastructure in which CRC investigators develop, implement, execute, monitor, and analyze CRC clinical trials and collect clinical information for patients enrolled in the CRC tissue bank. An Intranet-based Clinical Informatics Management System (CIMS) was developed to database clinical and laboratory information and monitor patients enrolled in the CRC tissue bank and treated on CRC multi-center clinical trials via an intranet in real-time.The CRC Clinical Research Core will have the following objectives: 1. Stimulate clinical trial development linked with correlative studies. Design, data collection and analyses of new protocols developed by CRC investigators will be fully supported. 2. Develop predictive models and identify and confirm prognostic factors for clinical endpoints including time to treatment, response to treatment, time to progression, and survival. 3. Develop systems for data exchange between different databases in order to increase access to available clinical data. 4. Further develop CIMS and patient database to assure complete, accurate clinical and laboratory data. 5. Provide a clinical trial-specific structure to utilize CIMS for CRC clinical trials. 6. Provide a platform in which CRC investigators performing laboratory studies interface with Biostatistics Core to request clinical information for analyses. 7. Coordinate CRC ClinicalAdvisory Committee activities. 8. Maintain complete regualtory documentation including IRB correspondence, SAE reports, FDA correspondence and audit results for all CRC clinical sites.
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