Review of new regulations for the conduct of clinical trials of investigational medicinal products
نویسندگان
چکیده
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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1 Association of the British Pharmaceutical Industry. Guidelines on good clinical research practice. London: ABPI, 1988. 2 Kessler DA. The regulation of investigational drugs. N Engl3JMed 1989;320:281-8. 3 Committee on Proprietary Medicinal Products, EEC. Recommended basis for the conduct of clinical trials of medicinal products in the European Community. Brussels: EEC (in press). (Document III...
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عنوان ژورنال:
- Bjog
دوره 114 شماره
صفحات -
تاریخ انتشار 2007