摘要
目的探讨质量管理(PDCA)循环法用于临床试验数据管理的可行性。方法考察某临床试验合同研究组织(CRO)2018年3月至2019年3月管理的临床试验项目20项,找出存在的问题,制订改进计划,以随机检查方式考察应用PDCA循环法管理前后数据质量,对比管理前后数据质量差异。结果管理后,数据名称及单位对应率,试验数据记录方法正确率,试验用药记录正确率分别提高75.00%,83.33%,66.67%。结论PDCA循环法能有效降低临床试验数据错误率,提高临床试验数据质量。
Objective To study the feasibility of Plan-Do-Check-Act(PDCA)cycle in data management of clinical trials.Methods A total of 20 clinical trials managed in a Contract Research Organization(CRO)from March 2018 to March 2019 were investigated to identify existing problems and formulate improvement plans.The data quality before and after the application of PDCA cycle was randomly checked,and the differences of data quality before and after the implementation were compared.Results After the implementation of PDCA management,the data name and unit correspondence rate,test data recording method accuracy rate,test medication record accuracy rate were increased to 75.00%,83.33%,and 66.67%.Conclusion PDCA cycle can effectively reduce the error rate of clinical trial data and improve the quality of clinical trial data.
作者
梅新路
MEI Xinlu(Zhejiang Pharmaceutical College,Ningbo,Zhejiang,China 315100)
出处
《中国药业》
CAS
2020年第10期88-90,共3页
China Pharmaceuticals
基金
浙江省食品药品监督管理与产业发展研究会科研课题[ZYH2018001]。
关键词
质量管理循环法
药物临床试验
质量控制
一致性评价
药事管理
Plan-Do-Check-Act cycle
drug clinical trial
quality control
consistency evaluation
pharmaceutical management
