摘要
目的:探讨PDCA循环管理法在持续改进临床试验药物质量管理中的应用价值。方法:采用PDCA循环管理法对药物临床试验进行管理,找出药物临床试验阶段中存在的问题并进行分析,采取相对应的解决措施,对于未能达到计划目标的措施进行调整、改善。结果:PDCA应用于持续改进临床试验药物的管理中,可以有效减少不良事件的发生,健全试验药物的管理体系,提高临床试验的质量管理效率。结论:PDCA循环管理法应用于临床试验药物管理中,效果显著,可有效降低不良事件的发生率。
Objective:To explore the application of PDCA cycle management method in continuous improvement of clinical trial drug quality management.Methods:The PDCA cycle management method was used to manage drug clinical trials.Find out and analyze the problems in the clinical trials of drugs,take corresponding solutions,and adjust and improve the measures that fail to reach the planned goals.Results:PDCA is applied in the continuous improvement of the management of clinical trial drugs,which can effectively reduce the occurrence of adverse events,improve the management system of trial drugs,and improve the quality management efficiency of clinical trials.Conclusion:The PDCA cycle management method is used in clinical trial drug management,and the management effect is significant,effectively reducing the incidence of adverse events.
作者
陶洁
邹淑琼
郑伟锋
TAO Jie;ZOU Shuqiong;ZHENG Weifeng(The Third Affiliated Hospital of Sun Yat-sen University,Guangzhou 510000,China)
出处
《临床医药实践》
2021年第8期610-612,共3页
Proceeding of Clinical Medicine
关键词
PDCA循环管理
临床试验药物
质量管理
PDCA cycle management
drugs for clinical trials
quality management
