| 美国药物临床试验受试者的损害补偿及其启示 |
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| 引用本文： | 沈玉红,张正付,李正奇.美国药物临床试验受试者的损害补偿及其启示[J].药学实践杂志,2013,31(4):271-272,276. |
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| 作者姓名： | 沈玉红 张正付 李正奇 |
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| 作者单位： | 国家食品药品监督管理局药品认证管理中心,北京,100061 |
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| 摘 要： | 目的 为推进我国药物临床试验受试者补偿机制的建立提供参考和意见.方法 探讨了美国对药物临床试验中的受试者损害责任的认定和补偿方案,并结合从中受到的启示为我国药物临床试验受试者补偿的实际情况提出建议.结论 在借鉴美国的受试者补偿方案的同时,建立具备我国自身特色的补偿机制,促进我国临床试验质量管理规范的切实实行.
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| 关 键 词： | 药物临床试验 受试者 权益保护 |
| 收稿时间： | 2012/6/21 0:00:00 |
| 修稿时间： | 2013/2/21 0:00:00 |
The damage compensation for participants in clinical trail in USA |
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| SHEN Yu-hong,ZHANG Zheng-fu and LI Zheng-qi.The damage compensation for participants in clinical trail in USA[J].The Journal of Pharmaceutical Practice,2013,31(4):271-272,276. |
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| Authors: | SHEN Yu-hong ZHANG Zheng-fu and LI Zheng-qi |
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| Institution: | Center for Drug Certification, State Food and Drug Administration, Beijing 100061, China,Center for Drug Certification, State Food and Drug Administration, Beijing 100061, China and Center for Drug Certification, State Food and Drug Administration, Beijing 100061, China |
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| Abstract: | Objective To give advice and reference for establishment of compensation mechanism of drug clinical trial subjects in China. Methods The drug clinical trials to the subjects' impairment of the determination and compensation scheme liability in USA were discussed. The suggestions to the compensation for participant in China were put forward according to the experiences in USA and the actual situation in China. Conclusion The compensation mechanism in our country must be established in reference to the United States, which could promote the quality control standard for clinical trials the practical implement. |
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| Keywords: | drug clinical trial subject revelation |
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