| 对药物临床试验档案管理若干问题的探讨 |
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| 引用本文： | 卢芳,;陈仲林,;韩宝惠,;李颖则,;施黄萍,;姜丽岩.对药物临床试验档案管理若干问题的探讨[J].世界临床药物,2014(8):511-512. |
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| 作者姓名： | 卢芳 ;陈仲林 ;韩宝惠 ;李颖则 ;施黄萍 ;姜丽岩 |
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| 作者单位： | [1]上海交通大学附属胸科医院药物临床试验机构,上海200030; [2]上海交通大学附属胸科医院呼吸内科,上海200030; [3]上海交通大学附属胸科医院心外科,上海200030 |
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| 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。
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| 关 键 词： | 药物临床试验 档案管理 规范化 标准化 信息化 |
Review of the drug management archives in clinical trials |
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| Institution: | LU Fang, CHEN Zhong-lin, HAN Bao-hui, LI Yin-ze, SHI Huang-ping, JIANG Li-yan (1. Department of Drug Chinieal Trial; 2. Department of Respiratory; 3. Department of Cardiac Surgery, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 200030, China) |
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| Abstract: | 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. |
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| Keywords: | drug clinical trial files management standardization normalization informatization |
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