| 浅谈运用ISO9001质量管理体系基本理论指导药物临床试验的实施 |
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| 引用本文： | 孔小红,戚建伟,李萍,殷晓红. 浅谈运用ISO9001质量管理体系基本理论指导药物临床试验的实施[J]. 中国临床药理学与治疗学, 2009, 14(7): 837-840 |
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| 作者姓名： | 孔小红 戚建伟 李萍 殷晓红 |
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| 作者单位： | 南京医科大学附属南京第一医院,南京,210006,江苏 |
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| 摘 要： | 摘要药物临床试验全过程必须严格遵循三大原则——伦理原则、科学原则、法律原则进行。在此基础上，本院还将ISO9001质量管理体系的管理理念贯穿于药物临床试验全程质控中，从而进一步巩固并完善了临床试验机构内部的质保体系。
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| 关 键 词： | 1SO9001质量管理体系 药物临床试验 过程管理 |
Using the basic theory of ISO9001 quality management system to guide the implementation of drug clinical trial |
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| KONG Xiao-hong,QI Jian-wei,LI Ping,YIN Xiao-hong. Using the basic theory of ISO9001 quality management system to guide the implementation of drug clinical trial[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(7): 837-840 |
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| Authors: | KONG Xiao-hong QI Jian-wei LI Ping YIN Xiao-hong |
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| Affiliation: | (Nanjing Medical University, Affiliated Nanfing First Hospital, Nanjing 210006, Jiangsu, China) |
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| Abstract: | The whole process of drug clinical trial must be strictly followed by three major principles:ethi-cal, scientific and legal. On this basis, the hospital will also use ihe management concepts of ISO9001 quality management system throughout the entire pro-cess of quality control in drug clinical trial to further consolidate and improve the quality assurance system of the clinical trial. |
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| Keywords: | ISO9001 quality management system drug clinical test process administration |
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