【摘要】 药物临床试验是药品上市前安全性评估的关键环节，质量管理贯穿其执行过程的始终，其质量关系到上市后使用人群的安全和健康。疫苗临床试验研究机构作为保障试验质量和受试者安全权益的主体，应根据最新的法律法规和指导原则，逐渐建立完善疫苗临床试验质量保证体系，并结合疫苗临床试验全过程的质量控制，确保试验过程的规范性、试验结果的可靠性。本文通过查阅文献并结合贵州省疫苗临床试验机构的工作经验，就本机构质量管理实践进行分享与探讨。更多还原

【Abstract】 Clinical trials are the main procedure in the pre-market safety assessment of drugs,and quality management is carried out throughout the process. The quality of clinical trials is related to the safety and health of the medication population after drug marketing. As the main body to guarantee the quality of clinical trials and the rights and interests of the subjects,the vaccine trial research institutions should gradually establish and improve the quality assurance system of vaccine trials according to the latest laws,regulations,and guidelines,and combine the quality control of the process,to ensure the standardization of the trial process and the reliability of the results. This paper is based on a literature review and the work experience of vaccine trial research institutions in Guizhou Province,to share and discuss the quality management practice of institutions.更多还原