摘要
目的:实现药物临床试验电子化数据采集及管理,为我国药物临床试验信息化奠定基础。方法:自主研发药物临床试验电子化数据采集管理系统,并将其应用到实际的药物临床试验管理中。结果与结论:该系统采用B/S三层结构设计,具有用户管理、数据采集器设计和填写、质疑管理、统计分析及稽查留痕等功能模块。其应用提高了临床研究管理效率,节省了时间和管理成本,更好地保证了数据的真实性、准确性和完整性。
OBJECTIVE：To achieve good clinical trial electronic data collection and management so as to promote the information construction of clinical trial in China.METHODS：Clinical trial electronic data collection and management system was developed independently.It was adopted in the practice of clinical trial electronic management.RESULTS CONCLUSIONS：Clinical trial electronic data collection and management system applies B/S three-tier architecture and has functions of user management,design and filling of data collector,auditing management,statistical analysis and trail auditing.Application of system improves the efficiency of clinical research,reduces research time and cost and ensures authenticity,accuracy and completeness of data.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第41期3860-3862,共3页
China Pharmacy
关键词
药物临床试验
电子化
数据采集
数据管理
设计
应用
Clinical trial
Electronic
Data collection
Data management
Design
Application
