PDCA循环在新药临床试验项目质量管理中的应用
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摘要
目的:探讨PDCA应用于新药临床试验质量管理的可行性,促进临床试验质量管理工作持续改进。方法:采用PDCA循环质量管理模型,项目启动时制定质控计划,实施过程中规范研究者的临床试验行为,分阶段对试验实施情况进行质量检查,发现问题及时整改,并在下一个循环中列为质控要点,持续改进。结果:PDCA循环引入项目质量管理工作,可有效监控试验质量。结论:通过PDCA循环质量管理模型的实施,有效地提高了新药临床试验项目的质量。
Purpose:To explore the feasibility of applying the PDCA management model to quality management in clinical trials and to promote the continuous improvement of quality management in the clinical trials. Methods:The PDCA management method is adopted to improve the trial'squality. A quality control plan is developed at the initiation of the project. During the implementation process,the clinical trial behaviors of the investigators are regulated,and the quality of the trial is checked in different phases. Problems identified before are rectified and made to be the highlights of quality control in the next PDCA management cycle until they are eliminated.Results:The PDCA cycle is successfully introduced into the quality management in clinical trials,which can effectively monitor the quality and achieve the goals of high-quality trials. Conclusion:Through the implementation of the PDCA quality management model,the quality of clinical trials has been effectively improved.
Purpose:To explore the feasibility of applying the PDCA management model to quality management in clinical trials and to promote the continuous improvement of quality management in the clinical trials. Methods:The PDCA management method is adopted to improve the trial'squality. A quality control plan is developed at the initiation of the project. During the implementation process,the clinical trial behaviors of the investigators are regulated,and the quality of the trial is checked in different phases. Problems identified before are rectified and made to be the highlights of quality control in the next PDCA management cycle until they are eliminated.Results:The PDCA cycle is successfully introduced into the quality management in clinical trials,which can effectively monitor the quality and achieve the goals of high-quality trials. Conclusion:Through the implementation of the PDCA quality management model,the quality of clinical trials has been effectively improved.
引文
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[4]鲁萌,王健,朱静静,等.医院药物临床研究协调员工作现状的调查分析[J].中国临床研究,2017,30(4):543-5.
[5]寇莹莹.肿瘤专科医院药物临床试验质量控制与质量保证体系的构建[J].江苏卫生事业管理,2015,26(6):45-46.
[6]彭朋,元唯安,胡薏慧,等.《国家食品药品监督管理总局关于发布药物临床试验数据现场核查要点的公告》解读[J].中国新药杂志,2016,25(7):771-4.
[7]刘文娜. PDCA循环在中药临床试验项目质量管理中的应用[J].北京中医药,2009,28(3):204-5.
[2]程晓华,杨茗钫,吕农华,等.基于PDCA循环的药物临床试验质量管理[J].医药导报,2014,33(8):1111-3.
[3]李爱剑.临床试验的关键环节节译自WHO《GCP手册:指南的补充》(2005年)[J].中国临床药理学与治疗学,2006,11(3):357-60.
[4]鲁萌,王健,朱静静,等.医院药物临床研究协调员工作现状的调查分析[J].中国临床研究,2017,30(4):543-5.
[5]寇莹莹.肿瘤专科医院药物临床试验质量控制与质量保证体系的构建[J].江苏卫生事业管理,2015,26(6):45-46.
[6]彭朋,元唯安,胡薏慧,等.《国家食品药品监督管理总局关于发布药物临床试验数据现场核查要点的公告》解读[J].中国新药杂志,2016,25(7):771-4.
[7]刘文娜. PDCA循环在中药临床试验项目质量管理中的应用[J].北京中医药,2009,28(3):204-5.