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文中研究了欧美临床试验药物安全报告体系,以为我国制药企业提供启示和借鉴。对欧美制药企业临床试验药物安全报告体系进行信息检索、梳理、汇总、分析和归纳。研究发现制药企业申办者作为欧美临床试验安全监督系统不良事件安全报告的主体,发挥了巨大的作用;而作为制药企业发挥作用的基础,其不良事件分类方法和报告方式、快速报告制度和汇总报告体系都具有重大的学习借鉴价值。
This article has studied the European and American clinical trials drug safety reporting system, in order to provide inspiration and reference for the pharmaceutical companies in our country. Information Retrieval, Combing, Summarizing, Analyzing and Summarizing the Drug Safety Reporting System of Clinical Trials in European and American Pharmaceutical Enterprises. The study found that the sponsor of pharmaceutical companies played a huge role as the main body of the adverse event safety report of the clinical trial safety supervision system in Europe and the United States. As the basis for the pharmaceutical enterprises to play a role, the classification methods and reporting methods of adverse events, rapid reporting system and summary report System has a significant learning value.