Protocol Review and Monitoring

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The CCCWFU Protocol Review and Monitoring System (PRMS) provides oversight for the processes of protocol development, protocol review, and protocol monitoring. These processes support internal oversight of the scientific quality, protocol prioritization and progress evaluation of cancer clinical trials. Protocol development in managed by PRMS staff who coordinate workflow as well as data requirements of the Protocol Review Committee (PRC) as well as the Protocol Operations Workgroup (POW). PRC faculty members evaluate the scientific merit of studies to ensure these fit within and programmatic focus of the CCCWFU. The PRC examines a protocol's relationship to the institutional cancer patient population and unmet patient needs and assesses the feasibility of a proposed protocol's accrual target. The committee assigns protocol priority as follows: 1) institutional investigator-initiated protocols, 2) cooperative groups, and 3) industry studies. Within these groups, emphasis is given to those protocols which target CCCWFU Program goals. The POW evaluates the operational and logistical feasibility and resources requirements of protocols in development. The POW reports its findings to the PRC. Protocol development is completed by a formal review process, with peer-reviewed evaluation of protocols by members of the PRC. The PRC also reviews all amendments to protocols. Protocol monitoring occurs throughout the span of patient accrual and analysis. Ongoing safety analysis is accomplished by the Clinical Research Oversight Committee (CROC) and the data safety and monitoring board (described in section 12). In addition, the Biostatistics shared resource and informatics groups provide interim analyses to facilitate the process of protocol monitoring.