临床试验源数据的管理

发布时间：2019-03-21 15:57

【摘要】：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。
[Abstract]:The source data and its source files are an important part of the clinical study data. With the continuous improvement of clinical trial technology, the source data of clinical trial shows the trend of electronic. The current source data of clinical trials in our country is in the state of both paper and electronic form. Based on the definition of the source data and the related concepts, the paper lists the specific forms of the paper source data and the electronic source data, and points out the advantages of the electronic source data. At the same time, the source data collection mode, the traceability, the quality standard, the management authorization, the file storage, the security guarantee and the like are also required for the source data management.
【作者单位】： 中国临床试验数据管理学组;
【分类号】：R95
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本文编号：2445094