DATA AND SAFETY MONITORING

达特茅斯-希区柯克医学中心（DHMC）的莫里斯科顿癌症中心（NCCC）排名最高， 优先保障参与临床试验患者的安全。Morris Cotton Cancer的照片 达特茅斯中心全面负责监督数据和安全监测。成团 数据和安全性监测的职责包括临床癌症研究委员会（CCRC）， NCCC安全和数据监查委员会（SDMC），临床办公室的内部稽查系统 研究（OCR），外部/独立的数据安全和监测委员会，NIH的主要研究者 支持临床试验的赠款和合同，最重要的是，达特茅斯的首席研究员 每一项临床试验 在NCCC进行的每项临床试验都必须包括安全性和数据监测计划，作为 议定书监查计划和报告要求取决于研究申办者、 研究药物（即，药物、生物制品或器械）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。的 OCR向SDMC提交所有未受其他机构监测的达特茅斯临床试验的报告 数据和安全性监查委员会（DSMB）。NCCC SDMC，负责监督患者的监测 试验期间的安全性、科学完整性、方案入组和方案终点进展 进展，也在完成试验，按照美国国立卫生研究院（NIH） 安全性和数据监查委员会指南。SDMC审查每个方案的进展， 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。

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.