The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice
FDA Law Blog
FEBRUARY 27, 2025
Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.
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