Clinical Research Core

$931,692P01FY2007CANIH

University Of California, San Diego, La Jolla CA

Investigators

Linked publications & trials

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Abstract

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

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