DATA AND SAFETY MONITORING

数据和安全监控

• 批准号: 7944685
• 负责人: RAYMOND P PEREZ
• 金额: $ 2.91万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-21 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944685
• 关键词: Address; Adverse event; Biological Products; Cancer Center; Cancer Center Support Grant; Chairperson; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Conduct Clinical Trials; Data; Devices; Enrollment; Ensure; Frequencies; Gossypium; Grant; Guidelines; Individual; Medical center; Monitor; Multi-Institutional Clinical Trial; Nature; Participant; Patients; Pattern; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Principal Investigator; Procedures; Protocols documentation; Publishing; Randomized; Reporting; Research Design; Research Ethics Committees; Research Personnel; Risk; Safety; Serious Adverse Event; Severities; Specific qualifier value; Structure; Study Subject; Support Contracts; System; Time; Toxic effect; United States National Institutes of Health; anticancer research; authority; base; design; empowered; handbook; high risk; human subject protection; meetings; patient safety

Morris Cotton Cancer Center (NCCC) at Dartmouth-Hitchcock Medical Center (DHMC) places the highest priority on ensuring the safety of patients participating in clinical trials. The Director of Morris Cotton Cancer Center at Dartmouth holds the overall responsibility for overseeing data and safety monitoring. Groups with responsibilities for data and safety monitoring include the Clinical Cancer Research Committee (CCRC), the NCCC Safety and Data Monitoring Committee (SDMC), the internal auditing system of the Office of Clinical Research (OCR), outside/independent data safety and monitoring boards, the principal investigators of NIH grants and contracts supporting clinical trials, and, most importantly, the Dartmouth principal investigator of each clinical trial. Every clinical trial conducted at the NCCC must include a plan for safety and data monitoring as part of the protocol. The monitoring plans and reporting requirements are dependent upon the study sponsor, nature of the investigational agent (i.e., drug, biologic product or device), and phase of trial. Specific plans may vary based on the degree of risk involved in participation and the size and complexity of the clinical trial. The OCR submits reports to the SDMC on all active Dartmouth clinical trials that are not monitored by another Data and Safety Monitoring Board (DSMB). The NCCC SDMC, which oversees the monitoring of patient safety, scientific integrity, protocol enrollment, and progress toward protocol endpoints while trials are in progress and also at the completion of trials, operates in accordance with National Institutes of Health (NIH) guidelines for safety and data monitoring committees. The SDMC reviews the progress of each protocol and is empowered to take any actions deemed necessary in order to protect safety, assure integrity of scientific data, and facilitate the timely completion of studies.

达特茅斯-希区柯克医疗中心(DHMC)的莫里斯棉花癌症中心(NCCC)排名最高 优先确保参与临床试验的患者的安全。莫里斯棉花癌症中心主任 达特茅斯中心负责监督数据和安全监测。群组： 数据和安全监测的责任包括临床癌症研究委员会(CCRC)、 NCCC安全和数据监测委员会(SDMC)，临床办公室的内部审计系统 研究(OCR)，外部/独立的数据安全和监测委员会，NIH的主要调查人员 支持临床试验的赠款和合同，最重要的是，达特茅斯大学的首席研究员 每一次临床试验。 在NCCC进行的每一项临床试验都必须包括安全和数据监测计划，作为 协议。监测计划和报告要求取决于研究赞助商的性质 研究试剂(即药物、生物制品或设备)和试验阶段。具体计划可能会有所不同 根据参与的风险程度以及临床试验的规模和复杂性。这个 OCR向SDMC提交关于所有未由另一家公司监督的活跃的达特茅斯临床试验的报告 数据和安全监控委员会(DSMB)。NCCC SDMC，负责监督患者的监测 安全性、科学完整性、方案登记，以及在试验期间朝着方案终端的进展 进展，也在试验完成时，根据美国国立卫生研究院(NIH)的规定运作 安全和数据监测委员会指南。国家发改委审查每个议定书的进展情况，并 有权采取任何必要的行动，以保护安全，确保科学的完整性 数据，并促进及时完成研究。