Abstract
European good clinical practice (GCP) guidelines are currently under review and development for regulatory implementation. The cultural differences, regulatory requirements, harmonization status, and project management issues are reviewed with specific emphasis on multinational, multicenter studies. The use of written informed consent, institutional review boards, and source documentation are key areas, along with adverse event reporting, in understanding the differences in culture, language, and medical practices between countries. A centralized management approach with a peripheral force for monitoring these projects is essential for success.
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