临床试验机构办在试验项目质量控制体系中的作用  

Role of clinical trial institutions in the quality control system of pilot projects

作　　者：王胤凯 孙浩[1] 王维聪 樊松 王佳庆[1] WANG Yin-kai;SUN Hao;WANG Wei-cong;FAN Song;WANG Jia-qing(Clinical Trial Center,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京天坛医院临床试验中心,北京100070

出　　处：《中国医院药学杂志》2020年第7期815-817,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的:为提高某院临床试验整体质量,降低在临床试验实施过程中诸多混杂因素对临床试验质量的不良影响。方法:该院机构办建立并实施临床试验项目3期质量控制体系,汇总已完成三期质量控制体系的5个项目,对质量控制中出现的问题进行讨论分析。结果:经过3期质控体系的临床试验项目质量得到了显著提升。结论:该体系的实施满足我院机构办对临床试验全流程的监管,为机构办参与临床试验质量控制体系建设提供新思路。OBJECTIVE In order to improve the overall quality of clinical trials in our hospital,reduce the adverse effects of many confounding factors on the quality of clinical trials during the implementation of clinical trials.METHODS Our institute established and implemented the third phase quality control system of the clinical trial project,and summarized five projects that have completed the third phase of the quality control system,and discussed and analyzed the problems in the quality control.RESULTS The quality of clinical trial projects has been significantly improved through the three-phase quality control system.CONCLUSION The implementation of the system satisfies the supervision requirements of the whole process of clinical trials by the institution of our hospital,and provides new ideas for the institutional office to participate in the construction of clinical trial quality control system.

关 键 词：临床试验 质量控制 机构办公室 

分 类 号：R975[医药卫生—药品]