Quality management practice of vaccine trial research institutions
FENG Tian
ZHANG Rui-zhi
GUAN Qing-hu
GAO Yuan-xue
JIAO Yu-hang
CHEN Hu
CHEN Zai-qin
HUANG Xiao-chan
MU Qiu-yue
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.
Keywords：vaccine clinical trialquality management practicequality control
Publication Date：2026-01-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 177-182 )