Data and Safety Monitoring Committee

数据与安全监测委员会

• 批准号: 8181162
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 2.53万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8181162
• 关键词: Adverse event; Amendment; Appearance; Area; Attention; Authorization documentation; Cancer Center; Cancer Patient; Categories; Charge; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Committee Members; Conduct Clinical Trials; Data; Decision Making; Diagnostic Trial; Disease; Doctor of Philosophy; Documentation; Eligibility Determination; Ensure; Event; Faculty; Goals; Guidelines; Institutes; Letters; Malignant Neoplasms; Medical; Monitor; Participant; Patients; Pediatric Hospitals; Pharmacologic Substance; Phase; Phase III Clinical Trials; Procedures; Process; Protocol Compliance; Protocols documentation; Reporting; Research Activity; Research Ethics Committees; Research Infrastructure; Research Personnel; Review Committee; Risk; Role; Safety; Study Subject; Suspension substance; Suspensions; Therapeutic Intervention; Time; Universities; Update; authority; behavioral clinical trial; computerized data processing; data integrity; design; falls; meetings; multidisciplinary; patient safety; programs; web site

Data and Safety Monitoring Committee (DSMC) The DSMC is the Data and Safety Monitoring Board (DSMB) for the SCC. The DSMC is a multidisciplinary committee charged with overseeing the monitoring of safety of participants in clinical trials, and the conduct, progress, validity, and integrity of the data for all clinical trials at the SCC. The committee meets monthly (see Meeting Section below for details). If a study is already being monitored by a data and safety monitoring committee formed by a national cooperative group, a pharmaceutical sponsor or a study-specific committee for a Phase III trial, the DSMC does not actively monitor the study. In this case, the DSMC reviews adverse event reports to ensure patient safety and that reporting requirements are met. The DSMC is chaired by Susan Knox, PhD, MD, Faculty Director of the CROG. Sandhya Srinivas, MD serves as the Vice Chair. The 22-member committee is multidisciplinary with a constituency that is representative of the different disease areas, departments, and roles encompassing cancer clinical trials. The DSMC committee meets monthly to review recently audited studies, adverse event reports, and protocol deviations. All clinical trials require monitoring, at a minimum once per year, commensurate with the degree of risk involved in study subject participation, the size and complexity of the study, and relevant findings from previous study audits. The DSMC focuses its internal auditing efforts on investigator-initiated (institutional) clinical trials, especially those for which there is no independent outside monitoring program. The DSMC Chair assigns a category of risk to every investigator-initiated study approved by the Scientific Review Committee (SRC); this category of risk determines the level of internal auditing required. Internal auditing is focused on protocol and regulatory compliance. Auditing includes a comprehensive review of all regulatory documentation, confirming eligibility of participants, verifying data validity and integrity, and assuring protocol compliance. The DSMC has the authority to require protocol amendments and to recommend suspension or termination of any research activities that fall within its jurisdiction. The DSMC can institute any other appropriate conditions needed for subject safety and protocol compliance. When the DSMC recommends suspension, or study closure, the Chair or Vice Chair notifies the PI and the IRB by letter at the same time. The Director of the CROG, the Associate Director of Clinical Research, and the Chair of the SRC are also informed.

数据和安全监控委员会 (DSMC) DSMC 是 SCC 的数据和安全监控委员会 (DSMB)。 DSMC 是一个多学科委员会，负责监督临床试验参与者的安全性以及 SCC 所有临床试验数据的实施、进展、有效性和完整性。该委员会每月举行一次会议（详情请参阅下面的会议部分）。如果某项研究已经由国家合作团体、药品申办者或 III 期试验研究特定委员会组成的数据和安全监测委员会进行监测，则 DSMC 不会主动监测该研究。在这种情况下，DSMC 会审查不良事件报告，以确保患者安全并满足报告要求。 DSMC 由 Susan Knox 博士、医学博士、CROG 教务主任担任主席。 Sandhya Srinivas 医学博士担任副主席。该委员会由 22 名成员组成，是一个多学科委员会，其选区代表了癌症临床试验中不同疾病领域、部门和角色。 DSMC 委员会每月召开一次会议，审查最近审核的研究、不良事件报告和方案偏差。 所有临床试验都需要每年至少进行一次监测，监测范围与研究对象参与的风险程度、研究的规模和复杂性以及之前研究审核的相关结果相一致。 DSMC 的内部审计工作重点关注研究者发起的（机构）临床试验，特别是那些没有独立外部监测计划的临床试验。 DSMC 主席为每项由研究者发起并经科学委员会批准的研究分配风险类别 审查委员会（SRC）；此类风险决定了所需的内部审计水平。内部审计的重点是协议和法规的合规性。审计包括对所有监管文件的全面审查，确认参与者的资格，验证数据的有效性和完整性，并确保协议合规性。 DSMC 有权要求修改方案并建议暂停或终止属于其管辖范围内的任何研究活动。 DSMC 可以制定受试者安全和协议合规性所需的任何其他适当条件。当 DSMC 建议暂停或结束研究时，主席或副主席会同时写信通知 PI 和 IRB。 CROG 主任、临床研究副主任和 SRC 主席也已获悉。