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.

Keywords

• Addendum
• International Council for Harmonisation
• investigator
• regulatory
• sponsor