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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.

Original publication

DOI

10.2515/therapie:2008022

Type

Journal article

Journal

Therapie

Publication Date

03/2008

Volume

63

Pages

83 - 82

Keywords

Adult, Child, Delivery of Health Care, Developing Countries, Drug-Related Side Effects and Adverse Reactions, Humans, Informed Consent, Pediatrics, Research, Specimen Handling