Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an introduction to ICH-GCP.
The Story of ICH-GCP: An introduction for investigators and site staff
This overview covers the historical background, context and evolution to ICH-GCP, summarises its key principles and describes the role of regulatory authorities. The talk highlights some of the accomplishments of ICH-GCP but also critiques some aspects of GCP application in non-pharmaceutical settings.
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The goal of the Global Health Clinical Trials Programme is to promote and make easier the conduct of non-commercial clinical research across all diseases in resource-poor settings. We present a series of short lectures to provide an introduction to clinical trials and explore some of the challenges facing clinical trialists in resource-limited settings.