Data and Safety Monitoring

NCI要求所有临床试验和所有涉及受试者风险的临床研究都有书面数据 和安全监控(DSM)计划。自上一届CCSG以来，癌症中心已经有了一个批准的计划 2002年进行了竞争性续签。 对于风险超过最低限度的研究，DSM计划有三个要素： 1)学习团队(ST) 2)独立医生监测员(IPM)或数据和安全监测委员会(DSMB) 3)监督委员会(MC)。 研究小组定期召开会议，审查研究行为，包括数据质量和受试者安全。_ 独立的医生监测器(IPM)和DSMB提供对以下研究事件的独立评估 受试者安全和在某些情况下的科学目标的术语(例如，提前停止规则和/或 中期分析)。独立的医生监测员直接与研究团队交互，并审查MC 报告。独立的医生监视器和DSMB报告被转发给调查人员、PRMS和 IRB。独立的医生监测器和dsmb没有改变研究的独立权力。 品行。 监督委员会(S)(MC)监督执行议定书的科学完整性和及时性， 包括法规遵从性、患者资格、协议遵从性、数据管理流程、 不良事件报告程序和应计项目。MCS向独立调查人员报告他们的调查结果 监视器和DSMB，以及PRMS。MCS没有改变研究行为的独立权力。 PRMS审查议定书、拟议的知情同意书和修正案。PRMS还审查了 从调查人员、MC、独立医生监督员和dsmb收到的报告。PRMS评估 在一个关注科学价值的持续过程中，从所有这些来源获得的信息， 包括主体安全和科学进步。PRMS有权暂停、修改或 终止礼仪行为。

The NCI requires that all clinical trials and all clinical research involving risk to subjects have a written data and safety monitoring (DSM) plan. The Cancer Center has had an approved plan since the previous CCSG competitive renewal in 2002. For research involving more than minimal risk, a DSM plan has three elements: 1) A study team (ST) 2) Either an Independent Physician Monitor (IPM) or a Data and Safety Monitoring Board (DSMB) 3) A Monitoring Committee (MC). The study teams hold regular meetings to review study conduct, including data quality and subject safety. _ Independent Physician Monitors (IPM) and the DSMB provide an independent assessment of study events in terms of subject safety and, in certain situations, scientific goals (for example, early stopping rules and/or interim analyses). Independent Physician Monitors interact directly with Study Teams as well as review MC reports. Independent Physician Monitor and DSMB reports are forwarded to investigators, the PRMS, and the IRB. Independent Physician Monitors and DSMB have no independent authority to alter research conduct. Monitoring Committee(s) (MC) monitor the scientific integrity and timeliness of the pursuit of a protocol, including regulatory compliance, patient eligibility, protocol compliance, data management processes, adverse event reporting procedures, and accrual. MCs report their findings to investigators, Independent Monitors and DSMB, and to PRMS. MCs have no independent authority to alter research conduct. The PRMS reviews protocols, proposed informed consent forms, and amendments. The PRMS also reviews reports received from investigators, MC, Independent Physician Monitors, and DSMB. The PRMS assesses the information received from all these sources in an ongoing process that focuses on scientific merit, ncluding subject safety, and scientific progress. The PRMS has the authority to suspend, modify, or terminate protocol conduct.