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 to review newly submitted interventional protocols. The PRMC has three functions: 1. Review protocols for scientific merit and prioritization to assure efficient use of HICCC resources;2. Monitor accrual and close trials that fail to demonstrate activity;3. Review and act on reports from the QA Committee. The PRMC also provides support to investigators regarding design of informed consents. The QA Committee conducts periodic audits on investigator initiated trials and reviews data audits conducted by cooperative groups and by trial sponsors/The QA also interacts with the IRB and with Theradex or other independent auditing groups to assure that there is periodic monitoring of the conduct of institutional trials at HICCC. The projected operating budget of the PRMS is $318,332, of which we are requesting $151,915 from the CCSG.
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