摘要
目的对比在临床试验药物管理过程开展品管圈活动前后的效果,探讨品管手法在医疗机构临床试验药物质量管理过程中的应用价值。方法运用品管圈的管理手法,分析临床试验药物管理过程中存在的主要问题,制定并实施具有针对性的对策和整改措施,评估有形成果和无形成果,细化工作流程,做到持续改进。结果开展品管圈活动之后,医疗机构内部临床试验药物管理差错数由活动前的95件减少到43件,进步率为54.7%,目标达标率为104%,圈员能力得到提升,试验药物的管理更为规范。结论开展品管圈活动有助于临床试验药物管理质量的持续改进,保障受试者用药安全,是对临床试验药物进行质量控制的重要方法。
OBJECTIVE To discuss the application value of the method of quality control circle（QCC） in quality management of clinical trial drugs in medical institutions by comparing the effect before and after the quality control circle activity. METHODS To analyze the main problems in clinical trial drugs management in medical institutions by using the method of QCC. It was formulated and implemented the targeted countermeasures and corrective measures, assessed the tangible and intangible results, detailed the workflow to be improved continuously. RESULTS After conducting the QCC activity, the inner error of clinical trial drugs management in medical institutions was reduced to 43 from 95. The progress rate was 54.7%, and the target rate was 104%. The ability of the crews was improved, and the management of clinical trial drugs was more standardized. CONCLUSION The QCC activity is helpful to improve the quality of the management of clinical trial drugs continuously, and to guarantee of medication safety of the subjects. It is an important method for the quality control of clinical trial drugs.
作者
王璐璐
刘慧
王健
WANG Lulu a;LIU Hui a;WANG Jian b(Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, a.Department of Pharmac;b.Office of Drug Clinical Trial Institution, Nanjing 210008, China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2018年第4期598-602,共5页
Chinese Journal of Modern Applied Pharmacy
基金
南京大学医学院管理研究所课题研究项目(NDYG2017010)
关键词
品管圈
临床试验药物
医疗机构
内部差错数
quality control circle
clinical trial drugs
medical institutions
inner error
