DATA AND SAFETY MONITORING

点击翻译按钮获取中文摘要

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.