PDCA循环法在药物临床试验机构资格认定中的应用

PDCA Cycle in Qualification of Drug Clinical Trial Institutions

目的:探讨PDCA循环法在徐州医科大学附属徐州儿童医院药物临床试验机构资格认定中的作用。方法:根据PDCA循环理论,分析我院目前药物临床试验机构资格认定工作存在的问题,针对硬件建设、人员培训、制度建设制定相关对策并进行持续改进。结果:通过PDCA循环,我院资格认定申请工作取得了较好的成绩,机构办公室、伦理委员会及申请的10个专业全部通过资格认定。结论:PDCA循环法的应用在我院药物临床试验机构资格认定工作中发挥了积极的促进作用。

Objective:To explore the role of PDCA cycle in the qualification of drug clinical trial institutions in Xuzhou Children’s Hospital,Xuzhou Medical University.Methods:Based on the theory of PDCA cycle,the existing problems in the qualification of drug clinical trial institutions of our hospital were analyzed,relevant countermeasures for hardware construction,personnel training and system construction were formulated,and continuous improvements were performed.Results:Through PDCA cycle,our hospital achieved significant results in the qualification.And the office of the institution,the ethics committee and the 10 majors had all passed the qualification.Conclusion:The application of PDCA cycle has played a positive role in the qualification of drug clinical trial institutions in our hospital.