CORE--DATA SAFETY/MONITORING

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The Mayo Comprehensive Cancer Center (MCCC) oversees patient safety, data monitoring, and protocol development and review through its Data and Safety Monitoring System (DSMS) and through the PRMS. The DSMS contains several elements including the Protocol Review Committee (PRC), Hematology Research Committee (HRC), Cancer Center Clinical Research Administrative Subcommittee (CCCRAS), and the Cancer Center Clinical Studies Oversight Committee (CCCSOC). These committees function in an integrated manner to monitor patient safety and data quality. Each committee has the authority to halt ongoing clinical research if concerns about patient safety are identified. Patient safety is further enhanced through the inclusion of required components to the procedural sections of MCCC sponsored clinical trials including early stopping rules. The operations and procedures of these committees are reviewed at least annually as part of the annual review of the Data and Safety Monitoring Plan. Each committee is also encouraged to periodically review its procedures and functions. The functions of these committees are also being integrated between the three sites of the MCCC.