CORE--DATA SAFETY/MONITORING

核心——数据安全/监控

• 批准号: 6990009
• 负责人: Franklyn G Prendergast
• 金额: $ 4.46万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6990009
• 关键词: biomedical facility; clinical research; computer data analysis; data collection methodology /evaluation; data management; data quality /integrity; experimental designs; health science research support; human data; neoplasm /cancer; patient safety /medical error; therapy adverse effect

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.

马约综合癌症中心（MCCC）负责监督患者安全、数据监测和 通过其数据和安全监测系统（DSMS）以及PRMS进行方案制定和审查。DSMS包含多个组成部分，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分委员会（CCCRAS）和癌症中心临床研究监督委员会（CCCSOC）。这些委员会以综合方式发挥作用，以监测患者安全和数据质量。如果发现对患者安全的担忧，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申办的临床试验的程序部分，进一步提高了患者安全性 包括提前停止规则。作为数据和安全性监测计划年度审查的一部分，至少每年对这些委员会的运作和程序进行一次审查。还鼓励各委员会定期审查其程序和职能。这些委员会的职能也在MCCC的三个地点之间进行了整合。