The Clinical Trials Office (CTO) was organized and implemented as a reflection of the Center leadership's commitment to increasing institutional and multimodality research, and to address the increasingly complex regulatory environment associated with clinical trials. Richard Wheeler, M.D., was recruited in late 1999 to establish and supervise the CTO, which has been supported primarily with institutional funds. The CTO is located on the second floor of HCI adjacent to the outpatient clinics and clinical faculty offices. It functions as a central administrative office for the implementation and conduct of internally and externally funded adult oncology studies. As a proposed clinical shared resource, the CTO is directly responsible to the Clinical Research Executive Committee (CREC). The CTO is administratively responsible for supervising protocol initiation and maintenance, quality control, regulatory compliance, budget development, and protocol educational activities. The CTO currently has 11 study coordinators who assist investigators in patient enrollment, study compliance, and data management. The specific objectives of the CTO are: . To support cancer center investigators with centralized protocol development, initiation, and management. . To assist in the preparation of protocols to the IRB, Clinical Cancer Investigations Committee (CCIC), and other review committees, as required by federal and University of Utah policy. . To process all regulatory documents, including submission of protocol amendments, revisions, adverse events, and annual renewals to the IRB, CCIC, and other applicable regulatory committees. . To negotiate budgets and contracts with study sponsors and the University of Utah Office of Sponsored Projects. . To assist investigators in the enrollment of study subjects. . To screen new patients for protocol eligibility. . To provide quality data to sponsors and ensure study compliance.
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