What ICH Harmonised Guideline Good Clinical Practice (GCP) E6(R3) requires
This guideline establishes unified standards for clinical trials to protect human subjects and ensure data integrity, applying to sponsors, investigators, and institutions. It mandates a quality-by-design and risk-proportionate approach to trial conduct, as outlined in the Principles section (e.g., Principle 1.1) and Annex 1.
Pillar: Medical & Healthcare · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf
SHA-256 integrity: 419a67dd85a9920f5d3ee0ee17b3b67960cd9cccd833ba56b75e5a449cde2daf
Primary Citations — 7 traced to source
- ICH E6(R3) Guideline: Principles
- ICH E6(R3) Guideline: Annex 1, Section 3 - Institutional Review Board / Independent Ethics Committee (IRB/IEC)
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