质量管理循环程序在临床试验用药物管理中的应用

Application of PDCA cycle in the clinical trial drug management

目的总结新版《药物临床试验质量管理规范》(good clinical practice,GCP)生效后,我院临床试验用药物管理的常见问题,分析其发生原因并找出优化对策。方法利用质量管理循环程序(plan、do、check、action,PDCA),使用帕累托图和鱼骨图对发现的问题进行根本原因分析,得出优化临床试验用药物管理的方案。结果通过PDCA循环工具优化临床试验用药物管理体系,使临床试验用药物管理中保存、转运以及回收环节问题减少率大于50%。结论PDCA能显著减少临床试验用药物管理过程中出现的问题,可以为临床试验用药物管理搭建更规范、更具可行性的平台。

Objective To summarize the common problems of drug management in clinical trial that happened in our hospital after the new version of good clinical practice(GCP)came into effect,and to analyze the reasons of these problems and find out the strategy.Methods The root causes of the problems were analyzed by using Quality Management Cycle Procedures(plan,do,check,and action,PDCA),Pareto diagram and Fishbone diagram.The optimized clinical trial drug management protocols were established.Results By using PDCA cycle tool to optimize the management system of clinical trial drugs,the problems in saving,transferring and recycling reduced more than 50%.Conclusions PDCA can greatly reduce the arising problem of clinical trial drug management.It can build a more standardized and more feasible platform for clinical trial drug management.