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Review of new regulations for the conduct of clinical trials of investigational medicinal products
Article first published online: 11 JUL 2007
RCOG 2007 BJOG An International Journal of Obstetrics and Gynaecology
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 114, Issue 8, pages 917–921, August 2007
How to Cite
Bollapragada, S., Norrie, J. and Norman, J. (2007), Review of new regulations for the conduct of clinical trials of investigational medicinal products. BJOG: An International Journal of Obstetrics & Gynaecology, 114: 917–921. doi: 10.1111/j.1471-0528.2007.01415.x
- Issue published online: 11 JUL 2007
- Article first published online: 11 JUL 2007
- Accepted 5 May 2007.
- Clinical trial regulations;
- EU directive;
- good clinical practice
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.