All clinical trials require monitoring.
All protocols in the Cancer Center will have a data safety and monitoring review. 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 Office of Biotechnology if required. Any questions regarding safety issues of the participants will be addressed directly to the Principal Investigator. Regular audits will be performed by the CRO to assure patient safety.