You have full text access to this OnlineOpen article

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

  1. SS Bollapragada1,*,
  2. JD Norrie2,
  3. JE Norman1

Article first published online: 11 JUL 2007

DOI: 10.1111/j.1471-0528.2007.01415.x

Issue

BJOG: An International Journal of Obstetrics & Gynaecology

BJOG: An International Journal of Obstetrics & Gynaecology

Volume 114, Issue 8, pages 917–921, August 2007

Additional Information

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

Author Information

  1. 1

    Division of Developmental Medicine, Maternal and Reproductive Medicine, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK

  2. 2

    Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, Aberdeen University, Aberdeen, UK

*Dr SS Bollapragada, Division of Developmental Medicine, Maternal and Reproductive Medicine, University of Glasgow, Third Floor, Queen Elizabeth Building, Glasgow Royal Infirmary, Glasgow G31 2ER, UK. Email bsshrikant@yahoo.com

Publication History

  1. Issue published online: 11 JUL 2007
  2. Article first published online: 11 JUL 2007
  3. Accepted 5 May 2007.

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (89K)

Keywords:

  • 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.

View Full Article (HTML) Get PDF (89K)