PROTOCOL REVIEW AND MONITORING SYSTEM

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The purpose of the Protocol Review and Monitoring System (PRMS) is to review the scientific merit, scientific priorities, and scientific progress of cancer-related studies that are conducted at the University of Chicago and that use UCCRC resources. The UCCRC PRMS is divided into two committees, the Clinical Trials Review Committee (CTRC), and the Scientific and Accrual Monitoring Committee (SAM), which are overseen by the Associate Director for Clinical Sciences (Dr. Mark Ratain) and the Clinical Research Advisory Committee (CRAC). A single Coordinator serves all three committees. The CTRC and SAM are composed of UCCRC members from all academic units and disciplines who have expertise in clinical trials. The CTRC meets monthly, and has primary responsibility for evaluation of the scientific merit, rigor, appropriateness of data and safety monitoring, and the relative prioritization of trials in the context of UCCRC goals and resources. CTRC and IRB review occur simultaneously, but protocol activation requires full CTRC approval. CTRC reviews are conducted by at least 3 individuals, including a biostatistician. Protocols may be approved, approved with revisions, deferred, or disapproved. Protocols that have undergone prior peer review (e.g., cooperative group protocols, NIH, ACS) are eligible for expedited review; that is, they are not required to be reviewed by the full committee, but rather will be reviewed by the Chair or Co-chair who have the option of bringing them to the full committee if there are specific concerns (e.g., design, prioritization). The SAM has primary responsibility for monitoring the scientific progress of CTRC-approved studies including accrual, minority accrual, overall progress towards meeting the study's objectives, as well as ensuring adherence to protocol procedures and UCCRC Data and Safety Monitoring requirements. The SAM meets monthly, and has the authority to close protocols that are not making adequate scientific progress, or that are not meeting adequate scientific or Data and Safety Monitoring guidelines.