Application and management of electronic data record system in the study of bioequivalence
10.13699/j.cnki.1001-6821.2019.07.034
- VernacularTitle:电子数据采集系统在生物等效性研究中的应用和管理
- Author:
Si-Yang NI
1
;
Shu-Min WANG
;
Feng WU
;
Shao-Jie GUO
;
Ying HAN
;
Yu-Yang DAI
;
Hui ZHOU
;
Xiu-Li ZHAO
Author Information
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
- Keywords:
electronic data record system;
bioequivalence;
management;
guidelines
- From:
The Chinese Journal of Clinical Pharmacology
2019;35(7):714-717
- CountryChina
- Language:Chinese
-
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.
