Review of new regulations for the conduct of clinical trials of investigational medicinal products
Authors: Bollapragada; Norrie1; Norman2
Source: BJOG: An International Journal of Obstetrics & Gynaecology, Volume 114, Number 8, August 2007 , pp. 917-921(5)
Publisher: Blackwell Publishing
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Abstract:
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.Keywords: Clinical trial regulations; EU directive; good clinical practice
Document Type: Research article
DOI: 10.1111/j.1471-0528.2007.01415.x
Affiliations: 1: Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, Aberdeen University, Aberdeen, UK 2: Division of Developmental Medicine, Maternal and Reproductive Medicine, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK
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