Data and Safety Monitoring Committee

数据与安全监测委员会

• 批准号: 8685181
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 5.95万
• 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 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8685181
• 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.

数据及安全监察委员会（DSMC）