质量循环管理法在药物临床试验质量控制中的应用与成效

Application and effect of quality circular management method in the quality control of drug clinical trials

目的探讨质量循环管理法(PDCA)在药物临床试验质量控制中的应用与成效。方法对药物临床试验质量控制中发现的原始数据记录问题进行统计分析,制定相应的对策干预。通过制定溯源计划表、开展专项入科培训、实施项目启动前考核和对病历实时督查等措施,对药物临床试验中发现的原始记录数据问题进行持续改进。结果循环管理后,出现原始数据记录问题的质控报告发生率由改善前47.22%降低到改善后的30.77%(χ2=3.872,P=0.049),改善明显;质控问题中原始数据记录问题占比由82.26%降低至63.64%(χ2=4.070,P=0.044),改善明显。结论质量循环管理法可以有效降低药物临床试验质量控制中原始数据记录问题的发生率,保证试验数据真实、可靠,保障药物临床试验质量。

Objective To explore the application and effect of quality circular management(PDCA)in the quality control of drug clinical trials.Methods The problems of original data recorded in the quality control of drug clinical trials were analyzed and the corresponding countermeasures and interventions were made.The original record data problems found in drug clinical trials were continuously improved through the establishment of traceability schedule,the implementation of special department training,pre-project assessment and real-time supervision of medical records.Results After the circular management,the incidence of quality control report with original data recording problems reduced from 47.22%to 30.77%(χ2=3.872,P=0.049),the improvement of which was obvious.The proportion of the original data in quality control problems decreased from 82.26%to 63.64%(χ2=4.070,P=0.044),the improvement of which was obvious.Conclusion Quality circulation management can effectively reduce the incidence of original data recording problems in the quality control of drug clinical trials,ensure the authenticity and reliability of test data,and ensure the quality of drug clinical trials.