PROTOCOL REVIEW AND MONITORING SYSTEM

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Since January 1996, a scientific review committee (Clinical Cancer Research Committee¿CCRC) and a Safety and Data Monitoring Committee (SDMC) have functioned at Norris Cotton Cancer Center. The CCRC reviews each new clinical trial protocol prior to Institutional Review Board (IRB) review, and the SDMC monitors safety and data integrity on a regular basis throughout the trial. Prior to IRB review, the NCCC Office of Clinical Research (OCR) submits the protocol to the CCRC. The CCRC is responsible for the scientific review of all new studies involving cancer patients or cancer prevention in human subjects. This assessment involves a review of all scientific aspects of the study, including the required safety and data monitoring plan. Once a protocol receives CCRC and IRB approval, the protocol is considered open for activation.