The Protocol Review and Monitoring System is composed of the Clinical Investigations (CIC) and Quality Assurance (QA) Committees. The objectives are to implement a multidisciplinary scientific peer-review process that ensures internal oversight of both the scientific and research aspects of clinical trials. The Clinical Investigations Committee is a multidisciplinary group of NCCC investigators and staff consisting of 30 individuals from a variety of schools, departments and divisions participating in the Cancer Center. NCCC policy requires that all intramural contract- or grant-supported NCI cooperative group-sponsored and pharmaceutical industry-sponsored clinical research protocols must be reviewed and approved by the CIC before submission to the IRB for activation. The protocols are reviewed by the CIC administrator and then presented to the full CIC where the protocol is reviewed in detail. Following a detailed discussion concerning the criteria set forth by the committee, the CIC members vote on approval/disapproval/ approval with minor changes/approval with revisions. Priorities are set by the Cancer Center program and CIC. In 1999 a total of 58 protocols were approved, including 12 intramural protocols. Nine were not approved and five were re-reviewed. The progress and conduct of clinical trials is monitored by the Quality Assurance Committee. The QAC is composed of 14 faculty from various disciplines. The QAC randomly selects 20 percent of patient cases entered into the CIC intramural protocols for auditing functions. In 1998 the QAC monitored a total of 202 protocols, including 68 intramural protocols. In 1999 of 92 protocol closures, 30 were for insufficient accrual.
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