医院临床试验中严重不良事件的伦理审查机制探讨

中华医学科研管理杂志 Pub Date : 2019-08-21 DOI:10.3760/CMA.J.ISSN.1006-1924.2019.04.018

Miaomiao Ye, Yuan Chen

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引用次数: 0

摘要

目的不断更新医院临床试验中严重不良事件(SAE)的伦理审查机制。方法分析严重不良事件的定义和SAE评审的现状，结合我院SAE评审的标准操作流程，以及改进的相关措施。结果目前SAE的报告和伦理审查还存在一些不足，伦理审查委员会应予以重视。结论在临床试验中有效、高效地进行SAE伦理委员会审查，有助于最大限度地保护受试者的健康和权利。关键词:临床试验;研究对象;伦理审查委员会;严重不良事件;标准操作程序

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Exploration of the ethical review mechanism of serious adverse events in hospital clinical trials

Objective To continuingly update the ethical review mechanism of Serious Adverse Events(SAE) in hospital clinical trials. Methods The definition of serious adverse events and the status quo of SAE review was analyzed, considering the standard operating procedures of SAE review in our hospital, as well as related measurements for improvement. Results At present, there still exists some disadvantages in the report and ethical review of SAE, which the ethical review committee should pay more attention. Conclusions It is important that the ethics committee review of SAE happened in clinical trial effectively and efficiently, which helps to maximize the protection of the subject's health and rights. Key words: Clinical trials; Subjects; Ethical review committee; Serious adverse events; Standard operating procedures

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中华医学科研管理杂志

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