Data and Safety Monitoring Committee

数据与安全监测委员会

• 批准号: 8281634
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 2.25万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8281634
• 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; Institutional Review Boards; 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 Infrastructure; Research Personnel; Review Committee; Risk; Role; Safety; Study Subject; Suspension substance; Suspensions; Therapeutic Intervention; Time; United States National Institutes of Health; 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.

数据和安全监测委员会(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进行、进展、有效性和完整性。委员会每月召开一次会议(详情见下文会议部分)。如果一项研究已经在由国家合作小组、药物赞助商或针对第三阶段试验的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不会积极监测该研究。在这种情况下，DSMC审查不良事件报告，以确保患者安全，并满足报告要求。 该委员会的主席是苏珊·诺克斯博士，医学博士，系主任。桑迪亚·斯里尼瓦斯医学博士担任副主席。这个由22名成员组成的委员会是一个多学科的委员会，其成员代表了癌症临床试验中不同的疾病领域、部门和角色。Dsmc委员会每月开会，审查最近经审计的研究、不良事件报告和方案偏差。 所有临床试验都要求至少每年监测一次，以与研究对象参与的风险程度、研究的规模和复杂性以及先前研究审计的相关结果相称。该委员会将内部审计的重点放在研究人员发起的(机构)临床试验上，特别是那些没有独立的外部监测计划的临床试验。DSMC主席为每个由科学家批准的研究人员发起的研究分配一个风险类别 审查委员会(SRC)；这类风险决定了所需的内部审计水平。内部审计的重点是礼仪和法规遵从性。审计包括对所有法规文件的全面审查，确认参与者的资格，验证数据的有效性和完整性，以及确保协议合规性。 该委员会有权要求修改方案，并建议暂停或终止其管辖范围内的任何研究活动。Dsmc可以为主体安全和协议合规性制定任何其他适当的条件。当美国医学委员会建议暂停或研究结束时，主席或副主席应同时以书面形式通知私人投资委员会和研究委员会。GROG主任、临床研究副主任和SRC主席也被告知。