| 初探如何加强医疗器械临床试验的伦理审查 |
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| 引用本文： | 孙文雄,葛晓珍,李剑,袁钊,罗旭俊,靳高凤.初探如何加强医疗器械临床试验的伦理审查[J].中国临床药理学与治疗学,2014(3):323-325. |
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| 作者姓名： | 孙文雄 葛晓珍 李剑 袁钊 罗旭俊 靳高凤 |
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| 作者单位： | [1]南昌大学第二附属医院药物临床试验机构办公室,江西南昌330006 [2]南昌大学临床药理研究所,江西南昌330006 |
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| 摘 要： | 通过对医疗器械临床试验的伦理审查内容、流程进行分析和评述，探讨其审查过程中需要重点关注的几个方面、以及执行过程中可能存在的问题及其解决方案，为医疗机构提高医疗器械临床试验伦理审查的质量和水平提供参考。
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| 关 键 词： | 医疗器械 临床试验 伦理审查 |
Exploration of how to strengthen the ethical review of medical apparatus clinical trials |
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| SUN Wen-xiong,GE Xiao-zhen,LI Jian,YUAN Zhao,LUO Xu-jun,JIN Gao-feng.Exploration of how to strengthen the ethical review of medical apparatus clinical trials[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2014(3):323-325. |
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| Authors: | SUN Wen-xiong GE Xiao-zhen LI Jian YUAN Zhao LUO Xu-jun JIN Gao-feng |
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| Affiliation: | 1 The Second Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi, China;2 Institute of Clinical Pharmacology, Nanchang University, Nanchang 330006, J iangxi, China) |
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| Abstract: | A systematic analysis on the content and process of ethical review is conducted to discuss review points and find an efficient way to solve current problems.To provide reference for medical institutions to improve quality and level of medical apparatus clinical trial ethics review. |
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| Keywords: | medical apparatus clinical trial ethical review |
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