title: Legal requirements for conducting clinical trials.
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.
authors.affiliation: School of Health Science, Swansea University. richard.griffith@swan.ac.uk
authors.forename: Richard
authors.initials: R
authors.lastname: Grffith
mesh_terms: D000328:Adult; D019985:Benchmarking / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D016903:Drug Monitoring; D004358:Drug Therapy / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence; D033242:Minors / Q000331:legislation & jurisprudence; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D011637:Public Health Nursing / Q000331:legislation & jurisprudence; D017751:Safety Management / Q000331:legislation & jurisprudence; D013222:State Medicine / Q000331:legislation & jurisprudence; D006113:United Kingdom