临床试验数据远程监查和稽查应用系统的构建  

Construction of data remote monitoring and auditing system for clinical trials

作　　者：沈亮 黄倩 翟优 裘云庆[2] 赵青威[2] 吴丽花[2] 周敏[1] 刘健[2] SHEN Liang;HUANG Qian;ZHAI You;QID Yunqing;ZHAO Qingwei;WULhug;ZHOU Min;LID Jian(Depagment o Infognation,the FirsO Afiliated Hospital,Zhejiang UcPersPh School of MedPne,Hangzhoo 310003,China;Research Center foe Clinical Pharmacc,Zhejiang Provincial Key Laboratorg for Drug Evaluatioo and Clinical Research,the Fie AfflliateP Hospital,Zhejiang UnPeyPh School of Medihine,Hangzhou 310003,China)

机构地区：[1]浙江大学医学院附属第一医院信息中心,浙江杭州310003 [2]浙江大学医学院附属第一医院临床药学研究中心浙江省药物临床研究与评价技术重点实验室,浙江杭州310003

出　　处：《浙江大学学报（医学版）》2020年第4期531-536,共6页Journal of Zhejiang University(Medical Sciences)

基　　金：十三五国家科技重大专项新药创制项目(2020ZX09201-003);浙江省科技厅重点研发计划应急攻关项目(2020C03123-7);省科技厅重点研发计划应急攻关项目(2020C03123-8);浙江省医药卫生科技计划(2018PY009)。

摘　　要：探索临床试验数据远程监查和稽查模式的可行性,提出具体的技术方案和系统功能,并对实现的场景进行构想。采用自主研发的临床试验信息管理平台,基本实现对临床试验全流程管理和全量数据采集。以该管理平台为数据基础,建立临床试验远程数据监查和稽查应用系统功能架构,通过对数据脱敏、数据加密等操作,以项目和受试者全息视图的模式进行可视化,方便对数据的审查。远程数据监查和稽查云平台采用浏览器和服务器(B/S)架构模式,用户通过云平台注册模块申请账号,并以超文本传输安全协议(HTTPS)访问,在线查看授权的相关审查项目,保证安全数据传输和操作便捷性。在遵守法律法规的前提下,应用信息技术手段实现远程监查和稽查,确保数据安全和个人隐私。数据的全电子化管理是未来努力和改进的方向。Clinical trial management system is independently developed by our hospital,which basically realized the whole process management and data collection of clinical trials.Based on the platform,the functional architecture of data remote monitoring and auditing was established.By desensitizing and encrypting of data,the project and subject hologram were visualized to facilitate to review of data.The data remote monitoring and auditing cloud platform adopts the B/S architecture pattern.Users register to apply for an account through the cloud platform,and access to the account via HTTPS security protocol.The authorized users were able to view the relevant items online to ensure the secure data transmission and easy operating.The electronic management of data is the direction of future efforts.By compliance with laws and regulations,the remote monitoring/auditing can be realized,and the data security and personal privacy can be ensured with the application of information technology.In this paper,the feasibility of remote monitoring/auditing mode is explored,specific technical schemes and system functions are suggested,and the realization scenarios are conceived in case of major public health emergencies.

关 键 词：临床试验 远程监查 远程稽查 临床试验管理平台 

分 类 号：TP319[自动化与计算机技术—计算机软件与理论]