摘要
在临床研究中,严重不良事件报告是保证受试者安全性的重要手段,既关系到研究者的利益,也关系到试验干预措施的安全性评价。本文从伦理审查的角度对临床研究中严重不良事件报告的有关要求进行梳理,对于报告过程中经常出现的问题进行探讨,旨在为临床研究者提供严重不良事件报告的基础性信息并提出常见问题的改进建议,提高报告的规范性,保护受试者安全。
In the clinical study, serious adverse event report is the important means to ensure the safety of the subjects. It is important for the interests of physician investigators and the safety assessment of interventions. In this paper, from the angle of ethics review, we showed regulatory requirements of serious adverse event report in clinical study, and discussed the problems that often occurred in the process of reporting. The aim is to provide physician investigators with basic information of the serious adverse event report, to make suggestions for improving report quality and ultimately to protect the participants in clinical study.
作者
李晓彦
张茜
刘赛男
梁伟雄
刘军
LI Xiao-yan ZHANG Xi LIU Sai-nan LIANG Wei-xiong LIU Jun(The Second Clinical College of Guangzhou University of Traditional Chinese Medicine ＆ Guangzhou Provincial Hospital of Traditional Chinese Medicine, Guangzhou GUANGDONG 510120, China)
出处
《中国新药与临床杂志》
CSCD
北大核心
2017年第7期393-396,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
国家科技重大专项-重大新药创制项目(2012ZX09303009-003)
广东省财政厅专项([2014]157号)
广东省中医院中医药科学技术研究专项(YN2015MS15)
关键词
临床试验
药物毒性
问题和对策
伦理学委员会
研究
clinical trial
drug toxicity
problems and solutions
ethics committees, research
