CLINICAL PROTOCOL AND DATA MANAGEMENT ABSTRACT Knight Clinical Protocol and Data Management (KCPDM) provides centralized support for the efficient and effective conduct of high-quality translational and clinical oncology research. The Knight Cancer Institute has expanded and restructured the KCPDM since 2010 to increase capacity and continue to enhance the quality of the services. The organization's 93 staff members offer comprehensive services including regulatory compliance, auditing and monitoring, protocol development, trial coordination, data management, research nursing, administration and financial operations, and reporting. In 2015, KCPDM administered 243 interventional clinical research studies and accrued 700 subjects on trial. The Knight Data and Safety Monitoring Plan (DSMP) focuses on oversight of subject safety and data integrity of studies not monitored by an external party. The plan was revised in 2015 to incorporate risk-based monitoring for Knight clinical research studies. Key elements of the monitoring includes a trial-specific monitoring plan addressing all critical elements of the research, implementation of the plan as evidenced through trial progress reports and the auditing and monitoring function. The Knight is committed to serving all residents in our catchment area, the state of Oregon. The Institute increased the rate of accrual of women in interventional clinical trials from 43% to 50% during the past five years. Minority group accruals continue to be in line with the Oregon Health & Science University (OHSU) cancer population. OHSU is actively engaged in clinical research in children with 53 interventional, treatment studies including subjects less than 18 years of age open in 2015 at OHSU. Among Oregonians accrued to interventional studies, 29% resided in rural regions which is similar to the rural population of our catchment area.
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