CORE--CLINICAL PROTOCOL AND DATA MANAGEMENT

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The Clinical Protocol and Data Management Shared Resource (CPDMSR) has four components. The Director coordinates the activities of the Resource and interactions with investigators and other MCC components such as PRMS, the Biostatistics Shared Resource, and MCC Information System. The Centralized Protocol Office (CPO) assists investigators with protocol development, sponsor relations, and regulatory affairs and facilitates communications, continuing education and development of information systems. Protocol development includes concept development and protocol drafting, development of grants and contracts, and planning for conduct of the research enterprise. Sponsor relations includes maintenance of grants and contracts. Regulatory affairs includes communication with all external and internal organizations with authority over protocol operations. CPO publishes a "protocol menu card" and maintains the MCC Website protocol list. CPO works to keep the clinical research community abreast of changing standards and requirements for the conduct of clinical research. CPO works with other MCC components to develop and maintain databases for monitoring clinical research as well as to develop databases for the conduct of specific protocols. Specialty-oriented RN/CRA teams assist investigators with the management of subjects and data. The RN mission is to assure that protocol procedures are accomplished within a context of high quality patient/subject care. The CRA mission is research documentation and adverse event reporting. RN and CRA personnel work with other MCC components to develop databases for the conduct and monitoring of clinical protocols. The Monitoring Committee consists of physicians, regulatory experts, and data management experts. All locally-initiated protocols are subject to Monitoring Committee visits. The purpose of these visits is to monitor regulatory and protocol compliance and data management processes.