临床试验质控数字化建设  

Digital construction of clinical trial quality control

作　　者：李彻 廖春梅 苏叶星 陈晶晶 蒋阳骏 刘一婷 龚瑛 刘燕飞 LI Che;LIAO Chun-mei;SU Ye-xing;CHEN Jing-jing;JIANG Yang-jun;LIU Yi-ting;GONG Ying;LIU Yan-fei(Clinical Research Unit,Fudan University Shanghai Cancer Center/Department of Oncology,Fudan University Shanghai Medical College,SHANGHAI 200032,China;Pfizer China Research and Development Co.,Ltd.,SHANGHAI 201203,China;Hangzhou Yikefu Technology Co.,Ltd.,Hangzhou ZHEJIANG 310012,China)

机构地区：[1]复旦大学附属肿瘤医院临床研究中心/复旦大学上海医学院肿瘤学系,上海200032 [2]辉瑞(中国)研究开发有限公司,上海201203 [3]杭州伊柯夫科技有限公司,浙江杭州310012

出　　处：《中国新药与临床杂志》2022年第5期276-279,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海申康医院发展中心管理研究项目(SKGL2001)。

摘　　要：为了有效提高临床试验机构风险识别的能力,本机构基于本院临床试验管理系统,进一步开展了临床试验质控数字化的建设。以2016年1月至2021年2月期间质控报告为研究对象,使用自动分类工具持续优化包含数据、质量、法规依从性、安全与伦理、财务等5个大类,4个等级的质量问题标准分类,实现质控报告批量化分析与结果可视化,提升了临床试验机构质量管理效率。In order to effectively improve the ability of clinical trial institutions to identify risks,our institution further develops the digital construction of clinical trial quality control based on the institution’s clinical trial management system.Taking the quality control report from January 2016 to February 2021 as the research object,the automatic classification tool was used to continuously optimize the standard classification of quality problems including five categories and four levels,including data,quality,regulatory compliance,safety and ethics,and finance.The digital construction of clinical trial quality control realizes the batch analysis of quality control reports and the visualization of results,and improves the quality management efficiency of clinical trial institutions.

关 键 词：临床试验 质量控制 信息系统 

分 类 号：R95[医药卫生—药学]