Central Protocol and Data Management Unit

PROJECT SUMMARY (See instructions): The CPDMU is a Shared Resource used by all AECC clinical cancer researchers that provides centralized management, communication, and oversight of all cancer clinical trials at the AECC. The CPDMU provides a central location for processing of all cancer related protocols, interaction with internal (e.g., IRB) and external (e.g., NCI, industry) agencies, and communication. The scope of work performed by the CPDMU includes processing of initial protocol submissions, amendments, internal and external safety and/or adverse event reports, and annual IRB progress reports, as well as patient registration, radiology review/tumor measurement, Data and Safety Monitoring Committee (DSMC reports, data management, and quality assurance). The CPDMU also supports other components of the clinical trials infrastructure, including the Protocol Review and Monitoring System (PRMS) and Protocol Specific Research Support (PSRS). Upon protocol activation, an announcement is distributed to all AECC investigators, and an updated list of currently active protocols is distributed on a monthly basis. The protocol status (open, suspended, closed to accrual) and most recently approved version of the protocol and IRB-approved consent is also posted on the CPDMU website so that it is accessible to all health care providers and research associates. Quality control functions include centralized education and training services for physicians, research nurses, physician assistants, and study coordinators. During the July 1, 2011 to June 30, 201212 grant year, the CPDMU processed 124 new protocols and 525 protocol amendments for review by the Protocol Review and Monitoring Committee (PRMC) and IRB, 5136 adverse events and 26 protocol monitoring reports for the DSMC, and 670 patient registrations requiring data management and processing.