疫苗Ⅰ期临床试验准备阶段的质量体系建设

Quality system construction in the preparation stage of phaseⅠvaccine clinical trial

疫苗临床试验的组织管理较一般药物临床试验更复杂、对质量管理的要求更高。本文从疫苗临床试验相关法律法规和指南梳理、机构和人员资质、试验场地要求、疫苗临床试验相关标准操作规程制定、伦理审查委员会要求这几个关键点入手,分析Ⅰ期临床试验准备阶段的质量体系建设的关注点,旨在为正在准备开展疫苗临床试验的同仁提供参考。

The organization and management of vaccine clinical trials are more complex than those of general drug clinical trials and require higher quality management.This article starts with the following key points:the relevant laws and regulations and guidelines,the qualifications of the institution and personnel,the requirements of site,the relevant standard operating procedures and the ethics review committee requirements to discuss the focus of the quality system construction in the preparation stage of vaccine clinical trials,hoping to provide reference for colleagues who are preparing to carry out vaccine clinical trials.