This topic was endorsed by the ICH Steering Committee in June 2014.

Since the adoption of the ICH E6(R1) Guideline on Good Clinical Practice (GCP) in 1996, clinical trials have evolved substantially, with increases in globalisation, study complexity, and technological capabilities.  To keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology it was agreed that the approach to GCP should be modernised to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality.

Modernising ICH E6 by supplementing it with additional recommendations will facilitate broad and consistent international implementation of new methodologies.