The Clinical Trials Office (CTO) provides a centralized and comprehensive infrastructure for the conduct of clinical trials involving cancer patients at Huntsman Cancer Institute (HCI). The CTO has evolved substantially since 2003 to reflect the Cancer Center's commitment to enhancing clinical research and to address the increasingly complex regulatory environment associated with clinical trials. The CTO functions as a central administrative office for the implementation and conduct of internally and externally funded adult oncology studies and integrates with the Pediatric Trials Office located at Primary Children's Medical Center for studies of cancers in children. The goals of the CTO are to 1) support Cancer Center investigators with all aspects of protocol development, initiation, implementation, management, and clinical study coordination; 2) prepare and process all regulatory documents for submission to the Institutional Review Board, Protocol Review and Monitoring System (known as the Clinical Cancer Investigations Committee at HCI), Data and Safety Monitoring Committee, Food and Drug Administration (FDA), and other regulatory committees, as required by federal and University of Utah (U of U) policies; 3) negotiate budgets and contracts with study sponsors and the U of U Office of Sponsored Projects; 4) manage billing and collection of study finances; and 5) provide quality data to regulatory committees and sponsors. The CTO is internally organized into specialty functions: regulatory, finance, and coordination. These groups are assigned to support specific organ-based tumor groups matching the HCI multidisciplinary clinical model. An independent group with a separate reporting structure oversees compliance. The CTO currently employs 35 staff and two faculty involved in study coordination, study compliance, data management, finance, regulation, specimen processing and collection of samples, research nursing, administration, protocol writing, grant development, and investigational new drug filing with the FDA. The CTO Shared Resource is managed by the Cancer Center with supervision by the Clinical Research Executive Committee chaired by Sean Mulvihill, MD, Senior Director of Clinical Affairs. The Funds are requested from the CCSG to cover 4 percent ($109,171) of the proposed CTO Shared Resource budget.
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