Clinical Protocol and Data Management

7.0. Abstract: Clinical Protocol and Data Management Clinical Protocol and Data Management (CPDM): The Clinical Research Management Office (CRMO) provides clinical trial management services to more than 35 investigators and oversees high-quality conduct and reporting of all cancer clinical trials at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) and the University of Maryland network sites. Comprising more than 50 full-time equivalent personnel, CRMO works closely with UMGCCC Disease/Modality Focused Groups (DFG) to manage a robust cancer clinical trial portfolio that prioritizes institutionally and externally peer-reviewed trials and complements UMGCCC's patient catchment area. CRMO utilizes the OnCore® database to track the conduct of and patient accrual to all oncology clinical trials and to centrally report clinical research activities to UMGCCC leadership. During the last grant period (CY2015–2019), CRMO supported the activation of 381 interventional clinical trials, resulting in 2,029 interventional trial enrollments during the reporting period. During FY2019, costs to support CPDM were $4,569,709, of which $204,148 were funded by the CCSG. Data and Safety Monitoring: UMGCCC's Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) serves the data safety monitoring function for protocols that do not have an external data and safety monitoring board (DSMB). The DSM/QAC annually reviews safety information for patients accrued to all oncology protocols considered “greater than minimal risk,” as defined in the UMGCCC-approved DSM Plan. This includes investigator-initiated trials of any phase, all Phase I trials, and selected industry Phase II trials without a sponsor-appointed DSMB, as well as multi-institutional, investigator-initiated trials for which UMGCCC is the coordinating center. During FY2019, costs to support DSM/QAC were $93,938, of which $23,592 were funded by the CCSG. This funding supported the annual review of 344 trials during the reporting period, as well as a percentage of salaries for three staff members.