| Academic clinical research in the new regulatory environment. | |
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MedLine Citation:
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PMID: 15745196 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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As a result of European legislation passed in 2001 (Directive 2001/20/EC), all clinical trials, whether sponsored by industry, a major national body or charity, or done by a single academic investigator, must get approval from the Medicines and Healthcare products Regulatory Agency (MHRA) as well as obtaining ethical approval. This requires all studies to be carried out to the standards of 'Good Clinical Practice' and places burdens on investigators in terms of reporting adverse events and archiving. A new directive has been published in draft form that will finally define what is meant by Good Clinical Practice in Europe. |
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Authors:
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Brian Gennery |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Clinical medicine (London, England) Volume: 5 ISSN: 1470-2118 ISO Abbreviation: Clin Med Publication Date: 2005 Jan-Feb |
Date Detail:
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Created Date: 2005-03-04 Completed Date: 2005-03-31 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 101092853 Medline TA: Clin Med Country: England |
Other Details:
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Languages: eng Pagination: 39-41 Citation Subset: E; IM |
Affiliation:
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Faculty of Pharmaceutical Medicine, London. bagqual@aol.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Academic Medical Centers
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ethics,
legislation & jurisprudence* Clinical Trials as Topic / ethics, legislation & jurisprudence* Ethics, Research European Union Great Britain Humans |
| Comments/Corrections | |
Comment In:
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Clin Med. 2005 May-Jun;5(3):299
[PMID:
16011226
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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