研究者发起的临床研究中电子数据采集系统的研究与实践  

Research and practice of electronic data capture system in investigator-initiated trial

作　　者：苏毓 覃开舟 许健[2] 刘如琦 徐婷 陆阳 吕文文 渠田田 沈恩璐 黄雪群 陈召霞 冯铁男 SU Yu;QIN Kaizhou;XU Jian;LIU Ruqi;XU Ting;LU Yang;LYU Wenwen;QU Tiantian;SHEN Enlu;HUANG Xuequn;CHEN Zhaoxia;FENG Tienan(Information Center,Hospital for Obstetrics and Gynaecology,Fudan University,Shanghai 200082,China;Information Center,Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai200092,China;Clinical Research Institute,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China)

机构地区：[1]复旦大学附属妇产科医院信息科,上海200082 [2]上海交通大学医学院附属新华医院信息科,上海200092 [3]上海交通大学医学院临床研究中心,上海200025

出　　处：《中国现代医生》2022年第34期111-115,共5页China Modern Doctor

摘　　要：目前,研究者发起的临床研究(investigator-initiated trial,IIT)缺乏完善的支撑体系,相较制药企业发起的注册临床试验(industry-sponsored clinical trial,IST),其信息化系统和管理体系都不完善。本研究对比分析了IIT和IST的差异点,参考电子数据采集(electronic data capture,EDC)系统的建设标准,结合服务于IIT研究的EDC系统现状分析,着重论述服务于IIT的EDC系统建设的关键要素,包括搭载具备迭代能力的标准数据字段库、更加灵活的支持研究者进行方案修改的功能模块、更加全面的原始资料备案和高效的数据管理模块及具备数据接口与功能的高度可扩展性。本研究基于上述原则形成具体示范案例。At present,investigator-initiated trials(IIT)lack a complete supporting system.Compared with industry-sponsored clinical trials(IST),its information and management systems are both incomplete.This study analyzed the differences between IIT and IST.According to the construction standard of electronic data capture(EDC)system,combined with the status analysis of EDC for IIT research,the key elements of the EDC system construction were focused on,comprising:standard data field library equipped with self-iteration ability,functional module supporting the scheme modification,comprehensive original data filing,efficient data management module,and high extensibility with a data interface and function.This study formed the specific demonstration case based on the above principles.

关 键 词：研究者发起的临床研究 制药企业发起的注册临床试验 电子数据采集系统 项目示范 

分 类 号：R969.4[医药卫生—药理学]