CORE--DATA SAFETY/MONITORING

梅奥综合癌症中心(MCCC)负责监督患者安全、数据监控和 通过其数据和安全监测系统(DSM)以及PRMS制定和审查协议。DSM包括多个组成部分，包括方案审查委员会(PRC)、血液学研究委员会(HRC)、癌症中心临床研究管理小组委员会(CCCRAS)和癌症中心临床研究监督委员会(CCCSOC)。这些委员会以一种综合的方式发挥作用，监测患者的安全和数据质量。如果确定了对患者安全的担忧，每个委员会都有权停止正在进行的临床研究。通过将所需组件纳入MCCC赞助的临床试验的程序部分，进一步提高了患者的安全性 包括提前停车的规定。这些委员会的运作和程序至少每年审查一次，作为数据和安全监测计划年度审查的一部分。还鼓励每个委员会定期审查其程序和职能。这些委员会的职能也在MCCC的三个地点之间整合。

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.