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 Universityof Chicago and that use UCCRC resources. The UCCRC PRMS is divided into two committees, theClinical 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 ClinicalResearch Advisory Committee (CRAC). A single Coordinator serves all three committees. The CTRCand SAM are composed of UCCRC members from all academic units and disciplines who haveexpertise in clinical trials. The CTRC meets monthly, and has primary responsibility for evaluation of thescientific merit, rigor, appropriateness of data and safety monitoring, and the relative prioritization oftrials in the context of UCCRC goals and resources. CTRC and IRB review occur simultaneously, butprotocol 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, ordisapproved. 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 fullcommittee, but rather will be reviewed by the Chair or Co-chair who have the option of bringing them tothe full committee if there are specific concerns (e.g., design, prioritization). The SAM has primaryresponsibility for monitoring the scientific progress of CTRC-approved studies including accrual, minorityaccrual, overall progress towards meeting the study's objectives, as well as ensuring adherence toprotocol 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 notmeeting adequate scientific or Data and Safety Monitoring guidelines.
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