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.
| Original language | English |
|---|---|
| Pages (from-to) | 917-921 |
| Number of pages | 5 |
| Journal | BJOG: An International Journal of Obstetrics and Gynaecology |
| Volume | 114 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 2007 |
Bibliographical note
RIS fileUN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 16 Peace, Justice and Strong Institutions
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