Data and Safety Monitoring Committee

数据与安全监测委员会

• 批准号: 8475471
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 2.06万
• 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/8475471
• 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.

数据和安全性监查委员会（DSMC） DSMC是SCC的数据和安全监测委员会（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监测，以及SCC所有临床试验数据的实施、进展、有效性和完整性。委员会每月举行一次会议（详见下文会议部分）。如果一项研究已经由国家合作小组、药物申办者或III期试验研究特定委员会组成的数据和安全性监查委员会进行监查，则DSMC不会主动监查该研究。在这种情况下，DSMC审查不良事件报告，以确保患者安全性并满足报告要求。 DSMC是由苏珊诺克斯，博士，医学博士，学院主任的CROG主持。Sandhya Srinivas，MD担任副主席。由22名成员组成的委员会是多学科的，其成员代表了不同的疾病领域，部门和癌症临床试验的角色。DSMC委员会每月召开一次会议，审查最近稽查的研究、不良事件报告和方案偏离。 所有临床试验都需要监查，至少每年一次，监查程度与研究受试者参与研究的风险程度、研究的规模和复杂性以及既往研究稽查的相关结果相称。DSMC将其内部审计工作重点放在制药商发起的（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主席为科学委员会批准的每项由制药商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。内部审计的重点是方案和法规遵从性。稽查包括全面审查所有监管文件，确认参与者的资格，验证数据有效性和完整性，并确保方案合规性。 DSMC有权要求修订方案，并建议暂停或终止其管辖范围内的任何研究活动。DSMC可以制定受试者安全性和方案依从性所需的任何其他适当条件。当DSMC建议暂停或关闭研究时，主席或副主席同时通过信函通知PI和IRB。还通知了CROG主任、临床研究副主任和SRC主席。