TY - JOUR
T1 - Review of new regulations for the conduct of clinical trials of investigational medicinal products
AU - Bollapragada, S. S.
AU - Norrie, J. D.
AU - Norman, J. E.
N1 - RIS file
PY - 2007
Y1 - 2007
N2 - 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.
AB - 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.
U2 - 10.1111/j.1471-0528.2007.01415.x
DO - 10.1111/j.1471-0528.2007.01415.x
M3 - Article (Academic Journal)
VL - 114
SP - 917
EP - 921
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
SN - 1470-0328
IS - 8
ER -