电子数据获取系统在临床研究质量控制中的应用优势讨论  

Predominance of electronic data capture system in the quality control of clinical study

作　　者：李伟[1,2] 熊宁宁[2] 卜擎燕[2] 邹建东[2] 汪秀琴[2] 

机构地区：[1]南京中医药大学 [2]南京中医药大学附属医院临床药理科,南京210029

出　　处：《中国新药杂志》2009年第12期1081-1083,1086,共4页Chinese Journal of New Drugs

基　　金：国家科技支撑计划课题(2006BA104A21-4)

摘　　要：以电子数据获取(EDC)为特征的临床研究数据管理系统可以有效保障临床研究的质量,采取的措施有:依从相关法规与指南制定管理系统;通过赋权伦理委员会、保护受试者隐私、保证知情同意过程等手段满足医学研究的伦理学要求;设置标准化结构采集数据;增强系统的数据录入功能;为监查/稽查提供技术支撑等。EDC系统将在现代临床研究中成为不可忽视和替代的新生力量,全面有效地推动医学科学事业快速进步。The purpose of this article is to discuss the electronic data capture （EDC） system that is developed by us to serve the clinical trial. This system can guarantee the high quality of clinical trials through depending on pertinent regulations and guidelines; satisfying the ethical need by powering the IRB, protecting the privacy of subjects, ensuring the process of ＂informed and consent＂ ; establishing the standard framework to collect the data; enhancing the system of the capability to record ; providing the auditor and monitor with the technical support, etc. It will grow up gradually to be an integrative system to serve the whole process of clinical study.

关 键 词：电子数据获取 临床研究 质量控制 

分 类 号：R95[医药卫生—药学]