| 药物临床试验院内质控的关键点 |
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| 引用本文： | 赵艳,王少华,李杨.药物临床试验院内质控的关键点[J].中国新药与临床杂志,2011(5). |
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| 作者姓名： | 赵艳 王少华 李杨 |
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| 作者单位： | 青岛市市立医院国家药物临床试验机构; |
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| 摘 要： | 随着新药临床试验科学性和规范性的加强,国内越来越多的药物临床试验机构相继建立和完善了各自的质量保证体系。"三级质控"的管理模式近年逐步推广并在临床试验质量控制方面发挥了巨大的作用。院内质控作为临床试验监督管理的重要形式,对保证临床试验质量更具有举足轻重的作用。笔者根据多年进行院内质控的经验,探讨了临床试验质量控制的关键点,并提出建议以供参考。
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| 关 键 词： | 临床试验 质量控制 全面质量管理 |
Key points of quality control in clinical trials |
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| ZHAO Yan,WANG Shao-hua,LI Yang.Key points of quality control in clinical trials[J].Chinese Journal of New Drugs and Clinical Remedies,2011(5). |
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| Authors: | ZHAO Yan WANG Shao-hua LI Yang |
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| Institution: | ZHAO Yan,WANG Shao-hua,LI Yang (Medical Institution Conducting Clinical Trials for Human Used Drug,Qingdao Municipal Hospital,Qingdao SHANDONG 266011,China) |
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| Abstract: | With scientificity and standardability strengthened in clinical trials,more and more domestic clinical institutions have established and improved their own quality assurance systems for clinical trials.Tertiary Quality Controlmanagement mode has been widely applied in the quality control of clinical trials in recent years,and plays a great role in promoting domestic clinical trial quality.Quality control system in clinical institutions is also very important in ensuring the quality of clinical trials.Based ... |
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| Keywords: | clinical trials quality control total control management |
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