【摘要】 临床研究中数据与安全监察委员会的设立在于保护受试者的安全与收益,即有效性和安全性。文章针对黑龙江中医药大学附属第一医院妇科临床基地一项大型不孕症临床研究中数据与安全监察委员会的成立、人员组成、运行和具体职能进行论述。详细阐述其批准研究方案优化与实施、督促伦理动态审查、推进研究进度、严格把控入组标准、审定偏离与违反界定、聚焦不良反应事件收集等具体职能。探讨和分享相关的实践经验,为数据与安全监察委员会在我国临床试验领域的科学合理应用提供参考。更多还原

【Abstract】 The establishment of the Data and Safety Monitoring Board(DSMB) in clinical trial is to protect the safety and benefit of the subjects, namely the effectiveness and safety of the trial. This article discussed the establishment, personnel composition, operation and specific functions of the DSMB of a large infertility clinical trial in the gynecological clinical base in the First Affiliated Hospital of Heilongjiang University of Chinese Medicine. This article demonstrated the specific functions of DSMB in detail, such as the approval of the optimization and implementation of trial protocol, urging the ethics of dynamic review, promoting trial progress, strict control inclusion criteria, validation definition of deviation and violation, focusing on the collection of adverse eventsand other specific functions. This article explored and shared relevant experience, and provided reference for the scientific and rational application of DSMB in clinical trial in China.更多还原