The Protocol Review and Monitoring System consists of the Protocol Review and Monitoring Committee(PRMC) and its subcommittee, the Quality Assurance Committee (QA). The PRMC meets biweekly toreview newly submitted interventional protocols. The PRMC has three functions: 1. Review protocols forscientific merit and prioritization to assure efficient use of HICCC resources; 2. Monitor accrual and closetrials that fail to demonstrate activity; 3. Review and act on reports from the QA Committee. The PRMCalso provides support to investigators regarding design of informed consents.The QA Committee conducts periodic audits on investigator initiated trials and reviews data auditsconducted by cooperative groups and by trial sponsors/The QA also interacts with the IRB and withTheradex or other independent auditing groups to assure that there is periodic monitoring of the conduct ofinstitutional trials at HICCC.The projected operating budget of the PRMS is $318,332, of which we are requesting $151,915 from theCCSG.
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