临床试验源数据的管理Source data management in - 药学学报.PDF

药学学报 Acta Pharmaceutica Sinica 20 15, 50 ( 11): 1367 1373 ·1367 · 床试验源数据的管理 * 何奕辉, 姚 晨, 张子豹, 刘玉秀 执笔 ( 中国临床试验数据管理学组) 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 、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。 关键词: 临床试验; 数据管理; 源数据; 源文件; 管理要求 中图分类号: R969 文献标识码: A 文章编号: 0513-4870 (20 15) 11-1367-07 Source data management in clinical researches * HO Effie, YAO Chen, ZHANG Zi-bao, LIU Yu-xiu (On Behave of Clinical Trial Data Management Working Group of China ) Abstract : Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: ① important concepts of source d