品管圈在持续改进药物临床试验质量中的应用

目的利用品管圈的管理方法持续改进药物临床试验质量。方法以"持续改进药物临床试验质量"为主题,通过品管圈的管理手法,归纳收集临床试验质量控制报告表、方案违背报告,找出导致药物临床试验质量缺陷的主要原因,制定并实施对策,评估有形成果和无形成果。结果南京大学医学院附属鼓楼医院药物临床试验质量缺陷数量由品管圈活动前的91件减少到活动后的43件,改善幅度为52.75%,目标达标率为106.67%。同时,圈员解决问题的能力和沟通协调能力得到显著提升,药物临床试验管理更为规范。结论开展品管圈活动有助于持续改进药物临床试验质量,不断提高药物临床试验管理水平。

Application of Quality Control Circle on Continuously Improving the Quality of Drug Clinical Trials

OBJECTIVE Continuous improvement of the quality of drug clinical trials by quality control circle (QCC). METHODS Continuous improvement of the quality of quality reports of drug clinical trials was chosen as the subject. By using the method of QCC, summary and collection quality control reports and protocol violation forms to analyze the main causes leading to the quality defects of drug clinical trials. It was formulated and implemented countermeasures, evaluated tangible and intangible achievements. RESULTS After the QCC activities, the number of defects in drug clinical trials in our hospital decreased from 91 to 43, the improvement rate was 52.75 %, the target rate was 106.67 %, the ability of the crews to solve problems and to coordinate has been significantly improved, and the management of drug clinical trials was more standardized. CONCLUSION The QCC activities are helpful to continuing improve the quality of drug clinical trials and continuously improve the management level of drug clinical trials.