中国临床药理学杂志2019，Vol.35Issue(7)：714-717,4.DOI:10.13699/j.cnki.1001-6821.2019.07.034
电子数据采集系统在生物等效性研究中的应用和管理
Application and management of electronic data record system in the study of bioequivalence
倪四阳 1王淑民 1武峰 1郭韶洁 1韩颖 1戴玉洋 1周辉 1赵秀丽1
作者信息
- 1. 首都医科大学 附属北京同仁医院 国家药物临床试验机构,北京 100730
- 折叠
摘要
Abstract
The electronic data record system (EDRS) is an useful tool in recording and managing data of clinical trials. The EDRS has characteristics of usability, real-time, high efficiency, error correction, and data manage function. It obviously promotes the efficiency and quality of data record of clinical trials. Meanwhile, as the EDRS is a newly sprouted thing, there are still problems in its stability, data integrity, etc. Here, based on our practical experiences, the applicaiton, usual management, and shortcomings of the EDRS were introduced.关键词
电子数据采集系统/生物等效性研究/管理/指导原则Key words
electronic data record system/bioequivalence/management/guidelines分类
医药卫生引用本文复制引用
倪四阳,王淑民,武峰,郭韶洁,韩颖,戴玉洋,周辉,赵秀丽..电子数据采集系统在生物等效性研究中的应用和管理[J].中国临床药理学杂志,2019,35(7):714-717,4.
