What ICH E6(R3) Good Clinical Practice Guideline (2026) requires
ICH E6(R3) provides the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants. It emphasises quality-by-design, risk-based monitoring, proportionality, data governance, decentralised trial designs, and use of technology while protecting participant rights, safety, and well-being. Adopted January 2025 and effective in most ICH regions from early 2026.
Pillar: Medical & Healthcare · Authority: International Council for Harmonisation (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://www.ich.org/page/efficacy-guidelines
SHA-256 integrity: 30b5dc2e1798ad236773755565157cd37cc7a2cd07c122ef3782fab824f3dd01
Primary Citations — 6 traced to source
- ICH E6(R3) Guideline, Section 1 (Glossary and definitions)
- ICH E6(R3) Guideline, Section 3 (Institutional Review Board / Independent Ethics Committee)
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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