Clinical Protocol and Data Management (CPDM)

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM): Clinical Protocol and Data Management (CPDM). Clinical research at the University of Arizona Cancer Center (UACC) is supported by the UACC Clinical Trials Office (CTO), which functions as the UACC Clinical and Protocol Data Management (CPDM) resource. The CTO staffing includes 79 FTEs to support UACC investigators conducting both interventional and non-interventional cancer clinical trials. The CTO supports Institutional, National Clinical Trials Network, Externally Peer-Reviewed, and Industry-sponsored clinical trials, and provides comprehensive services for the entire trial lifecycle, including regulatory support, data management, clinical research coordination, research nursing, training and education, and technology services. The CTO uses a centralized clinical trials management system, OnCore, to manage protocol conduct and to provide reports and performance metrics to the Cancer Center leadership. These metrics facilitate oversight and strategic planning and support ongoing process improvement and training needs. In the current project period, the CTO oversaw the activation of 327 interventional trials and 23 non-interventional trials. In the same period, the CTO supported the accrual of 6,116 participants to interventional trials, 1,259 to interventional treatment trials, and an additional 4,857 to non-interventional trials. This included the activation of 71 new trials and the recruitment of 3,535 participants during the 2020 COVID-19 period (2,835 to interventional accruals of which 342 were to interventional treatment trials and 700 to non-interventional trials). Data and Safety Monitoring (DSM). All interventional trials are required to include a DSM plan. For UACC-led interventional investigator-initiated trials (IITs), UACC’s DSM Board (DSMB) approves and executes the DSM plan by performing risk-based monitoring to ensure the highest levels of patient safety. As a major new initiative, UACC is launching its Arizona Clinical Trials Network (ACTN) to improve clinical trial access to understudied populations across the Catchment Area and the entire state.