University of Michigan Comprehensive Cancer Center CCOP*

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DESCRIPTION (provided by applicant): The University of Michigan Comprehensive Cancer Center (UMCC), a matrix organized, NCO Core Grant supported Comprehensive Cancer Center, proposes a renewal of a CCOP Research Base focused solely on Cancer Prevention and Control. Over the last five years, the Research Base has established an infrastructure to develop, review, activate, manage data, and monitor clinical research. It has developed close collaborative relationships with eight CCOPs including three minority based CCOPs, is working on affiliation with two more CCOPs, activated three translational, extramurally peer reviewed and funded Cancer Prevention and Control Protocols and has one awaiting approval in the NCI CCOP review system. Progress in the development of a Web-based registration and sample tracking system has been made. The specific aims of this proposal are to: 1. To describe University of Michigan Cancer Center Research Base Organization 2. To describe how CCOPs are integrated into the Research Base Organization. 3. To outline the organization process for development and implementation of cancer prevention and control research. 4. To describe Cancer Prevention and Control Research for the next 3 years in the Research Base. 5. To describe Quality Control and Monitoring and 6. To demonstrate how the University of Michigan Cancer Center CCOP Research Base has supported and will continue to support enrollment of underserved minorities in translational Cancer Prevention Research. To meet these specific aims, the UMCCC CCOP Research Base has established the technical support to handle data meeting current Good Clinical Practice and NCI guidelines. These include internal data quality control methods, auditing procedures, data management methods, ADR reporting procedures, protections of human subjects, and performance guidelines for CCOPs. Governance of the CCOP consists of a CCOP Research Base Executive Committee, and a Data Safety and Monitoring Board. All concepts and protocols must be approved by Research Base PI or CoIs and Research Base biostatistician, the UMCCC Protocol Review Committee. Research focuses upon Phase I and II chemoprevention protocols, biomarker discovery and validation projects, and complementary and alternative medicine approaches to control and prevent cancer. Protocols are structured to provide the necessary preliminary data to merit consideration for larger trials requiring the resources of National Cooperative Groups. Affiliations with Minority Based CCOPs have been forged to enhance recruitment of underserved minorities.