International Council for Harmonisation E6(R2) addendum: Challenges of implementation

Abstract

The International Council for Harmonisation (ICH) E6 - good clinical practice (GCP) (R2) addendum - was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches - quality management system, risk-based monitoring with emphasis on human subject protection, and data integrity. The article discusses challenges in adoption and implementation of the changes in ICH GCP guideline for clinical trial stakeholders.