Abstract： Objective To explore the application effect of PDCA cycle in quality management of drug clinical trials，and to provide reference for improving quality management of drug clinical trials.Methods Since January 2019，PDCA cycle theory had been applied in the quality management of drug clinical trials of Jilin City People′s Hospital.First of all，management related problems during the implementation of drug clinical trials in Jilin City People′s Hospital from January to December 2018 were analyzed and summarized，and the relevant improvement measures were formulated to implement the PDCA cycle achieve continuous improvement.The occurrence of related problems in the course of drug clinical trial，such as non-standard record of case report，program deviation，adverse event reporting problem，trial drug management problem and informed consent problem before (2018) and after PDCA circulation theory implementation(2019) were compared，and the quality improvement effect after the implementation of PDCA circulation theory was analyzed.Results After the implementation of PDCA circulation theory in 2019，the total incidence of quality management related problems in drug clinical trials was 1.84%，which was lower than 10.17% in 2018，and the difference was statistically significant (P＜0.05).Conclusion The application of PDCA cycle in the quality management of drug clinical trials can improve the quality management model and improve the management quality of drug clinical trials.
宋纪伟. PDCA循环在药物临床试验质量管理中的应用[J]. 中国当代医药, 2020, 27(33): 188-190.
SONG Ji-wei. Application of PDCA cycle in quality management of drug clinical trials. 中国当代医药, 2020, 27(33): 188-190.
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