CORE--PROTOCOL SPECIFIC RESEARCH SUPPORT

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Description: (Applicant's Description) The Vermont Cancer Center's Protocol Review and Monitoring System (PRMS) provides a centralized system for review and monitoring of clinical trials as required by NCI. The Protocol Review Committee (PRC), where direct protocol review is conducted, was established in April of 1993 in response to NCI's policy statement dated December 7, 1992. Oversight is also provided by the Cancer Center's Clinical Research Oversight Committee (CROC) that was established in 1998. There is a system for identification of appropriate membership, a process and criteria for the review and monitoring operations, a system of prioritization of protocols, and a well-developed working and organizational relationship with the IRB. At the last review of our Cancer Center Support Grant in December 1996, the Protocol Review and Monitoring System received conditional approval and was recommended for early peer re-evaluation. That evaluation occurred in March 1999 and our Protocol Review and Monitoring System was "Approved" at that time.