All clinical trials require monitoring.
All protocols in the Cancer Center will have a data safety and monitoring review. The Data Safety Monitoring Boards including the PRMC and CTO will address the following issues. Mechanisms and procedures for reporting of adverse events All adverse events are reported to the IRB and the Cancer Center. They will also be reported to the NCI, FDA, NIH and other government agencies if required. The CTO and PRMC will also perform an annual review of all adverse events at the time of the protocol renewal.