| 国际多中心临床试验的监查 |
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| 引用本文： | 王文,马丽媛,邹效漫.国际多中心临床试验的监查[J].中国临床药理学与治疗学,2004,9(7):835-837. |
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| 作者姓名： | 王文 马丽媛 邹效漫 |
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| 作者单位： | 1. 中国医学科学院阜外心血管病医院,心血管病研究所,高血压中心,北京,100037
2. 中国人民解放军总医院内分泌中心,北京,100853 |
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| 摘 要： | 为贯彻临床试验管理规范，保证多中心临床试验的质量。本文以ADVANCE多中心临床试验为例，简介监查的程序和方法。提出监查员应当具有医药知识和临床试验经验，应当按程序到研究点去核查CRF，研究文件和有关资料。标准化的监查有助于提高多中心临床试验的质量。
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| 关 键 词： | 多中心 临床试验 质量 监查 |
| 文章编号： | 1009-2501(2004)07-0835-03 |
| 修稿时间： | 2004年6月15日 |
Monitoring in multicenter clinical trial |
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| WANG Wen,MA Li-Yuan,ZOU Xiao-Man Cardiovascular Institute,Fu Wai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing ,China, General Hospital of PLA,Beijing ,China.Monitoring in multicenter clinical trial[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2004,9(7):835-837. |
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| Authors: | WANG Wen MA Li-Yuan ZOU Xiao-Man Cardiovascular Institute Fu Wai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China General Hospital of PLA Beijing China |
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| Institution: | WANG Wen,MA Li-Yuan,ZOU Xiao-Man 1 Cardiovascular Institute,Fu Wai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China, 1 General Hospital of PLA,Beijing 100853,China |
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| Abstract: | In order to ensure the multicenter clinical trial quality by carrying out good clinical practice, the monitoring procedures and methods were introduced for the multicenter trial of ADVANCE. We suggest that the monitor should adequate medical and pharmaceutical qualifications and have the clinical trial experience. The monitor should visit each site to review the CRF, study files and data according to the procedures. Good monitoring is assistance to improve the quality of multicenter clinical trial. |
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| Keywords: | multicenter clinical trial quality monitoring |
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