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Therapie. 2008 Mar-Apr;63(2):83-8, 77-82. doi: 10.2515/therapie:2008022. Epub 2008 Jun 20.

Good clinical practice in developing countries: applying recommendations.

[Article in English, French]

Author information

1
Direction Accès au Médicament, Sanofi Aventis, Paris, France. francois.bompart@sanofi-aventis.com

Abstract

The recommendations for clinical research in developing countries were published in 2007 and the present article deals with issues which were not initially raised or discussed in depth. In particular, we discuss specific questions linked to trials conducted in developing countries with regard to informed consent, research project review by two ethics committees, standards of care, management of biological samples, study follow-up committees, notification of Serious Adverse Events, paediatric trials, and Contract Research Organizations.

PMID:
18561879
DOI:
10.2515/therapie:2008022
[Indexed for MEDLINE]
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