摘要
疫苗因其产品特性和受试人群的特殊性,对其临床试验的安全性要求较高,严重不良事件的发生与受试者权益紧密相关。通过对疫苗临床试验SAE报告现状进行分析与讨论,试图探索适合疫苗临床试验SAE伦理审查的机制。
The vaccine clinical trials require high security because of the product features and the special na- ture of the subjects. The occurrence of SAE （Serious Adverse Event） is closely related to subjects＇ rights and interests. The aim of the present was to explore the ethical review mechanism through analyzing and discussing the current situation of SAE reported in vaccine clinical trials.
出处
《中国医学伦理学》
2016年第1期14-16,共3页
Chinese Medical Ethics
关键词
疫苗临床试验
严重不良事件
审查机制
Vaccine Clinical Trials
SAE （Serious Adverse Event）
Review Mechanism
