The Story of ICH-GCP: An introduction for investigators and site staff

10/29/09 • 24 min

Clinical Trials in Resource-Limited Settings

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. 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.

Previous Episode

An Introduction to Clinical Trials

George Warimwe from the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya presents an introduction to clinical trials aimed at trial site staff and anyone new to the field. Topics covered include: equipoise and hypothesis, protocol, trial design, comparative effectiveness, pharmacovigilance, ICH-GCP basics, informed consent, essential documents, databases and statistics.

Next Episode

Introduction to Research Ethics

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 research ethics. This overview covers the historical origins and landmark events that have influenced current understanding of research ethics. Some of the major ethical codes and fundamental ethical principles are identified and their application in research is discussed. Finally, there is an overview of the role of ethics committees.