Review of new regulations for the conduct of clinical trials of investigational medicinal products

The EU Clinical Trials Directive came into force on 1 May 2004 and has changed the face of Clinical Trials of investigational medicinal products in the UK. An enthusiastic registrar or consultant who comes up with an idea for a therapeutic intervention now needs to comply with a complex and demandin...

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Detalles Bibliográficos
Autores principales: Bollapragada, SS, Norrie, JD, Norman, JE
Formato: Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2007
Materias:
Review Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1974829/
https://www.ncbi.nlm.nih.gov/pubmed/17635485
http://dx.doi.org/10.1111/j.1471-0528.2007.01415.x
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author Bollapragada, SS
Norrie, JD
Norman, JE
author_facet Bollapragada, SS
Norrie, JD
Norman, JE
author_sort Bollapragada, SS
collection PubMed
description The EU Clinical Trials Directive came into force on 1 May 2004 and has changed the face of Clinical Trials of investigational medicinal products in the UK. An enthusiastic registrar or consultant who comes up with an idea for a therapeutic intervention now needs to comply with a complex and demanding set of legal, ethical and regulatory requirements, contravention of which may lead to criminal proceedings. The aim of this review was to detail the relevant procedures and regulations and to provide a ‘user-friendly’ guide to obstetricians and gynaecologists wishing to conduct a clinical trial of an investigational medicinal product. Sources of further information are listed.
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spelling pubmed-19748292007-09-18 Review of new regulations for the conduct of clinical trials of investigational medicinal products Bollapragada, SS Norrie, JD Norman, JE BJOG Review Articles The EU Clinical Trials Directive came into force on 1 May 2004 and has changed the face of Clinical Trials of investigational medicinal products in the UK. An enthusiastic registrar or consultant who comes up with an idea for a therapeutic intervention now needs to comply with a complex and demanding set of legal, ethical and regulatory requirements, contravention of which may lead to criminal proceedings. The aim of this review was to detail the relevant procedures and regulations and to provide a ‘user-friendly’ guide to obstetricians and gynaecologists wishing to conduct a clinical trial of an investigational medicinal product. Sources of further information are listed. Blackwell Publishing Ltd 2007-08-01 /pmc/articles/PMC1974829/ /pubmed/17635485 http://dx.doi.org/10.1111/j.1471-0528.2007.01415.x Text en © 2007 The Authors Journal compilation https://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.
spellingShingle Review Articles
Bollapragada, SS
Norrie, JD
Norman, JE
Review of new regulations for the conduct of clinical trials of investigational medicinal products
title Review of new regulations for the conduct of clinical trials of investigational medicinal products
title_full Review of new regulations for the conduct of clinical trials of investigational medicinal products
title_fullStr Review of new regulations for the conduct of clinical trials of investigational medicinal products
title_full_unstemmed Review of new regulations for the conduct of clinical trials of investigational medicinal products
title_short Review of new regulations for the conduct of clinical trials of investigational medicinal products
title_sort review of new regulations for the conduct of clinical trials of investigational medicinal products
topic Review Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1974829/
https://www.ncbi.nlm.nih.gov/pubmed/17635485
http://dx.doi.org/10.1111/j.1471-0528.2007.01415.x
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