摘要
建设科学的档案管理,规范档案管理员的素质,对保障药物临床试验质量至关重要。本综述基于我院药物临床试验中的相关经验,着重探讨如何建立科学的药物临床试验档案管理体系规范,以保证药物临床试验质量。
It is important to establish rational archives management to improve the quality of drug clinical trial. Based on experience in drug clinical trials, this review focuses on how to establish a standard of archives management system for drug clinical trials, which can ensure the quality of drug clinical trials.
出处
《世界临床药物》
CAS
2014年第8期511-512,I0001,共3页
World Clinical Drug
关键词
药物临床试验
档案管理
规范化
标准化
信息化
drug clinical trial
files management
standardization
normalization
informatization
