CLINICAL PROTOCOL AND DATA MANAGEMENT ABSTRACT The Clinical Protocol and Data Management/Clinical Trials Office (CPDM/CTO) provides a centralized and comprehensive infrastructure and administrative office for the conduct of clinical trials involving adult cancer patients at Huntsman Cancer Institute (HCI); CPDM/CTO integrates with the Pediatric Trials Office located at Primary Children's Hospital for studies of cancers in children. The CPDM/CTO has been expanded and restructured since 2009, to reflect the Cancer Center's commitment to enhance clinical research and to address the increasingly complex regulatory environment associated with clinical trials. The CPDM/CTO employs 96 staff 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 CPDM/CTO implemented technologies, including the clinical trials management system, OnCore, to efficiently and effectively manage clinical research conducted at HCI. The CPDM/CTO is supervised by the Clinical Research Executive Committee. Since 2009, CPDM/CTO has revised, approved, and implemented a new Data Safety and Monitoring plan. The Data and Safety Monitoring Committee (DSMC) ensures that HCI conducts investigator-initiated clinical trials in adherence with local and federal regulations, as well as ensuring the accuracy, validity, and integrity of the study data. Data and Safety Monitoring is conducted at HCI for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I), efficacy studies (Phase II), and efficacy, effectiveness, and comparative trials (Phase III). HCI is committed to serving all residents of our catchment area, the State of Utah, including women, children, and underserved minorities, with excellent care and access to the latest advances in cancer treatment through participation in clinical research. To achieve this goal, HCI has followed an NCI-approved plan that involves goal-setting, outreach and community education, and facilitation/patient navigation. To reach rural residents of our state, as well as Utah's Native American populations, with clinical trials opportunities, HCI developed and formalized a research partnership with Intermountain Healthcare, the major clinical care provider in Utah. A key feature of the Huntsman-Intermountain Cancer Care Program is the agreement to interlink the data warehouses for the two organizations with the Utah Population Database to support clinical research. Through this linkage, complete diagnosis, treatment, and outcomes information is available on 85% of cancer patients in the state for approved research projects, increasing opportunities for cancer research on many fronts.
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