The overall aim of this proposal is to continue the role of UTMDACC as a Research Base in the Community Clinical Oncology Program (CCOP), by accomplishing the following objectives: 1) To provide NCI-approved treatment and cancer control protocols for CCOP participants; 2) To integrate the CCOP network into the clinical research program of UTMDACC; 3) To maintain the data management and quality assurance systems necessary to ensure data of the highest quality in this collaborative research program; 4) To develop cancer control programs which will generate a series of research protocols for CCOP investigators. The MDACC CCOP network will consist of thirty-four CCOPs in 24 states, four of which are new Minority CCOPS. It is estimated that these CCOPs will provide 537 patients (credits) for treatment protocols and 2241 subjects or 910 credits for cancer control protocols annually. Mechanisms for the development of cancer control protocols based on MDACC or CCOP concepts have been developed, utilizing CCOP staff as Principal Investigators (PI) or Co-PIs. Communication concerning the development of trials is accomplished by interactive meetings, a monthly newsletter with surveys, and a proposed electronic mail system. Data management using the MDACC computerized Protocol Data Management System has been adapted to multi-institutional trials, including a protocol data form tracking system. A complete quality assurance system has been devised. This includes a continuous monitoring of CCOP performance for eligibility, evaluability, data quality, and data timeliness. On-site audits will be performed on each CCOP every 18 months. Review of all major resources will be performed to assure concordance between MDACC and CCOP evaluations. Standardized forms and procedure manuals will be designed for all cancer control studies and appropriate quality assurance measures devised. The goal of the CCOP network is to optimize interactions between MDACC and CCOP investigators in the research of therapeutic and prevention interventions.
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