The damage compensation for participants in clinical trail in USA

SHEN Yu-hong; ZHANG Zheng-fu; LI Zheng-qi

doi:10.3969/j.issn.1006-0111.2013.04.008

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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.

The damage compensation for participants in clinical trail in USA

Center for Drug Certification, State Food and Drug Administration, Beijing 100061, China

Received Date: 2012-06-21

Rev Recd Date: 2013-02-21

Key words:

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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Reference (10)

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The damage compensation for participants in clinical trail in USA

doi: 10.3969/j.issn.1006-0111.2013.04.008

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通讯作者: 陈斌, bchen63@163.com

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