Legal requirements for conducting clinical trials.
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.
Grffith
Richard
R
School of Health Science, Swansea University. richard.griffith@swan.ac.uk
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