基于电子数据采集系统关键技术的临床研究数据库的构建-《中国医学物理学杂志》

文章信息/Info

Title:: Construction of clinical research database using EDC system key technology

作者:: 王勇1; 冯前进1; 2; 1.南方医科大学生物医学工程学院，广东广州 510515； 2.广东省医学图像处理重点实验室，广东广州 510515

Author(s):: WANG Yong1; FENG Qianjin1; 2; 1. School of Biomedical Engineering, Southern Medical University, Guangzhou 510515, China 2. Guangdong Provincial Key Laboratory of Medical Image Processing, Guangzhou 510515, China

Keywords:: Keywords: electronic data capture system clinical research database

摘要:: 规范化、高质量的临床研究数据库的构建是临床医师或科研工作者开展临床医学研究的重要环节，是获得高质量科研成果和论文发表的重要保障。本文总结分析了传统临床研究数据库创建的类型及存在问题，重点介绍了基于电子数据采集（EDC）系统进行高质量临床研究数据库构建的关键技术解决方案，包括中央随机与EDC系统的结合、逻辑核查、智能化随访管理、数据字典、痕迹追踪、数据分析与统计化等6大模块的技术创新方案来解决传统软件系统在构建临床研究数据库方面的不足，并对采用EDC系统构建临床研究数据库的应用效果进行了总结与展望，以期为临床医师或科研工作者开展高质量临床研究提供参考。

Abstract:: Abstract: The construction of standardized and high-quality clinical research database is an important link for clinicians or researchers to carry out clinical medical research, and also an important guarantee for obtaining high-quality scientific research results and publication. A review on the types and challenges of traditional clinical research database creation is provided, focusing on the key technical solutions of constructing high-quality clinical research database based on electronic data capture (EDC) system, including 6 modules of technological innovation program: the combination of interactive web response system and EDC system, logical check, intelligent follow-up management, data dictionary, trace tracing, statistical analysis of research data, so as to solve the deficiency of traditional software system in constructing clinical research database. In addition, the applications of EDC system in clinical research database construction are summarized and its development prospects are discussed for providing references for clinicians or researchers to carry out high-quality clinical researches.