第三方稽查在临床试验的云计算方法  

Third-party audit of cloud computing methods in clinical trials

作　　者：朱旭 黄虹[2] 程思杰 武晓捷[1] 张瑞雯 曹钰然[1] 何金杰 张海 朱颖 程书彦 国毅 周涛 张菁[1] ZHU Xu;HUANG Hong;CHENG Si-jie;WU Xiao-jie;ZHANG Rui-wen;CAO Yu-ran;HE Jin-jie;ZHANG Hai;ZHU Ying;CHENG Shu-yan;GUO Yi;ZHOU Tao;ZHANG Jing(Phase Ⅰ Clinical Laboratory,Huashan Hospital,Fudan University,Shanghai 200040,China;Information Center,Huashan Hospital,Fudan University,Shanghai 200040,China;Shanghai Biomedical Technology Industry Promotion Center,Shanghai 201203,China;Pharmaron(Beijing)New Drug Technology Co.,Lud.,Beijing 100176,China;Nanjing CR Medicon Technology Co.,Lid,Nanjing 211100,,Jiangsu Prouince,China;Shanghai Boehringer Ingelheim Pharmaceutical Co.,Ltd.,Shanghai 200120,China;Pfizer(China)Research and Development Co.,Lud.,Shanghai 200131,China)

机构地区：[1]复旦大学附属华山医院Ⅰ期临床研究室,上海200040 [2]复旦大学附属华山医院信息中心,上海200040 [3]上海市生物医药科技产业促进中心,上海201203 [4]康龙化成(北京)新药技术有限公司,北京100176 [5]南京希麦迪医药科技有限公司,江苏南京211100 [6]上海勃林格股格翰药业有限公司,上海200120 [7]辉瑞(中国)研究开发有限公司,上海200131

出　　处：《中国临床药理学杂志》2022年第15期1824-1826,共3页The Chinese Journal of Clinical Pharmacology

基　　金：科技部“重大新药创制”专项基金资助项目(2017ZX09304005)。

摘　　要：云计算是指在广域网或局域网内将硬件、软件、网络等系列资源统一起来,实现数据的计算、处理、共享和储存的一种托管技术。稽查是保障临床试验质量的重要手段,由独立的第三方开展稽查工作能够更好地发挥稽查保证临床试验质量的作用。随着智能化临床研究在我国的应用与临床研究的数字化转型,药物临床试验机构逐渐将数据从原传统的院内服务器向混合云迁移。药物临床试验机构邀请研发中心、制药公司及合同组织等5家单位中的质量保证员、法规专家、数据管理专家和稽查专家等组建的稽查工作组对国内某云计算供应商进行稽查,工作流程包括稽查前准备工作、稽查方法与程序、稽查发现问题的纠正和改进措施,达成第三方云计算稽查工作核心要素,加以总结与分析,供行业参考。Cloud computing refers to a hosting technology that integrates hardware and software network resources in a wide area network(WAN) or local area network(LAN) to realize data computing, processing, sharing and storage. Audit is an important means to ensure the quality of clinical trials. Independent third-party audit can better play the role of audit to ensure the quality of clinical trials. With the application of intelligent clinical research and the digital transformation of clinical research in China, the clinical research center transfers the data from offline to online, and transfers its business from the traditional servers which are in hospital to the mixed cloud gradually. The site set up a team comprised of several professors from 5 units to conduct an audit on a domestic cloud computing provider. The process included audit preparation, methods and procedures, and correction and improvement measures for problems found during the audit. Based on the summary and refinement of this audit, recommendations are formed for the reference of the industry.

关 键 词：临床试验 云计算 稽查 智能 

分 类 号：R97[医药卫生—药品]