Clinical Protocol and Data Management

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12.0 Abstract: Clinical Protocol and Data Management The Clinical Protocol and Data Management (CPDM) component of UMGCC comprises the personnel in the Clinical Research Management Office (CRMO), formerly defined as the Clinical Research Shared Service in the 2011 CCSG application, and the resources, including database and technical staff, supporting its operations. The CRMO participates with investigators in the various UMGCC Disease Groups or assists research support staff housed in other departments in UMB, as requested, in the design, review, implementation, monitoring, and reporting of all clinical protocols. This effort includes interactions with the Institutional Review Board (IRB) of UMB, the NCI Central IRB, the Clinical Research Committee (CRC; functioning as the Protocol Review and Monitoring System) of UMGCC, and the UMGCC Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) as well as other monitoring and auditing entities. CRMO utilizes the OnCore database to track enrollment of all patients, completing case report forms for industry- sponsored trials and entering data into appropriate databases for National Clinical Trials Network and Experimental Therapeutics Clinical Trials Network NCI-sponsored studies. During the last granting period encompassing CY2010–2014, the CRMO supported 200–250 protocols/year, resulting in 112 publications. The UMGCC DSM/QAC serves the data safety monitoring function for those protocols that do not have an external data and safety monitoring board (DSMB). The DSM/QAC annually reviews safety information for accrued patients to all “greater than minimal risk” (according to UMB IRB criteria) investigator-initiated trials of any phase, all Phase I trials, and selected industry Phase II trials without a sponsor-appointed DSMB, including multi-institutional investigator-initiated trials for which UMGCC is the coordinating center. During FY2014, costs to support CPDM were $3,159,534, of which $157,278 were from the CCSG. During FY2014, costs to support the DSM/QAC were $776,002, of which $78,500 were from the CCSG.