ICH GCP E6(R3)

The final version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6(R3) was adopted on 06 January 2025. The guideline has been restructured from the previous version E6 (R2). E6(R3) Section 4 (Data Governance - Investigator and Sponsor) now includes data governance, data lifecycle, and computerised systems.