源数据及其源文件是临床研究数据的重要组成部分。随着临床试验技术的不断进步,临床试验的源数据呈现出电子化的发展趋势。当前我国临床试验的源数据处于纸质和电子形式并存的状态。本文在明确定义源数据及相关概念的基础上,列举了纸质源数据和电子源数据的具体表现形式,并指出电子源数据的优势。同时,还从源数据的采集方式、可溯源性、质量标准、管理授权、文件保存、安全性保障等方面对源数据管理提出要求。 Source data and source files are an important part of clinical research data. With the continuous improvement of clinical trial techniques, the source data of clinical trials show the trend of electronic development. At present, the source data of clinical trials in our country is in the state of paper and electronic co-existence. Based on the clear definition of source data and related concepts, this paper lists the concrete manifestation of paper source data and electron source data, and points out the advantages of electron source data. At the same time, it also put forward requirements on source data management in terms of source data collection methods, traceability, quality standards, management authorization, document preservation, and security assurance.