What ICH Harmonised Guideline Good Clinical Practice (GCP) E6(R3) requires
This guideline provides a unified standard for the European Union, Japan, USA, and other regions on the conduct of clinical trials, emphasizing a quality-by-design and risk-based approach to protect human subjects and ensure the integrity of trial data. It applies to sponsors, investigators, and ethics committees involved in clinical research of pharmaceutical products.
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: a1a8c77bfa644fe614922a34b73c1186a1a2242f1316468f42666fdce5684747
Primary Citations — 5 traced to source
- ICH E6(R3) Guideline, Section 1: Principles of ICH GCP
- ICH E6(R3) Guideline, Section 2: Sponsor
+ 3 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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