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Legal requirements for conducting clinical trials.

作者信息

Grffith Richard

机构信息

School of Health Science, Swansea University.

出版信息

Br J Community Nurs. 2008 Jan;13(1):41-2, 44-6. doi: 10.12968/bjcn.2008.13.1.27984.

DOI:10.12968/bjcn.2008.13.1.27984
PMID:18399372
Abstract

Clinical trials are crucial to the development of new medicines as they test the safety and effectiveness of the drug on human subjects. However, trials do pose a risk to the participants. To minimize this risk all clinical trials must meet the requirements of the Clinical Trials Directive (Council Directive (EC) 2001/20 2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004. In this article Richard Griffith discusses the legal framework that regulates clinical trials in the United Kingdom.

摘要

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