ICH- E5 Guidance of Ethnic Factors in the Acceptability of Foreign Clinical Data
This document provides a comprehensive guidance on factors ethnic factors that should be considered when is provided with clinical services in a different region. The basis of this guidance stems from the desirability of regions in: European Union, United States of America and Japan (ICH Regions) to utilize foreign clinical data that meets the regulatory standards of clinical practices. It provides guidance on how ethnical factors may be applied in the ICH regions to ensure effective medical service provision in ICH foreign countries.
This article focuses on medical research ethics. It gives a comprehensive discussion on seven core principle Continue reading...
