Data and Safety Monitoring Committee

数据与安全监测委员会

• 批准号: 8375621
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 2.2万
• 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/8375621
• 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.

数据与安全监测委员会（DSMC） DSMC是SCC的数据和安全监控板（DSMB）。 DSMC是一个多学科委员会，负责监督参与者在临床试验中的安全性以及SCC所有临床试验的数据的行为，进度，有效性和完整性。委员会每月开会（有关详细信息，请参见下面的会议部分）。如果由国家合作组织，制药赞助商或特定研究的III期试验委员会组成的数据和安全监测委员会已经监控了一项研究，则DSMC不会积极监测这项研究。在这种情况下，DSMC审查了不良事件报告，以确保患者安全并满足报告要求。 DSMC由Crog教职员工苏珊·诺克斯（Susan Knox）博士主持。医学博士Sandhya Srinivas担任副主席。由22名成员组成的委员会是多学科的，其选区代表了包括癌症临床试验的不同疾病领域，部门和角色。 DSMC委员会每月开会，以审查最近审核的研究，不良事件报告和协议偏差。 所有临床试验都需要每年至少进行一次监测，与研究学科参与，研究的规模和复杂性以及先前研究审计的相关发现相称。 DSMC将其内部审计工作重点放在研究人员发起的（机构）临床试验上，尤其是那些没有独立外部监测计划的临床试验。 DSMC主席为每个研究人员发起的研究分配了风险类别 审查委员会（SRC）；此类别的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遵从性。审核包括对所有监管文档的全面审查，确认参与者的资格，验证数据有效性和完整性以及确保协议合规性。 DSMC有权要求协议修正案，并建议暂停或终止任何属于其管辖范围内的研究活动。 DSMC可以制定主题安全和协议合规性所需的任何其他适当条件。当DSMC建议暂停或学习关闭时，主席或副主席同时通知PI和IRB。 CROG的主任，临床研究副主任和SRC主席也得到了告知。