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: b74776409e559848b9c84ef7b38a147fc7a763bc2ecf8501774a777ca87c91e2
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)
+ 5 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/ich-e6-r3-good-clinical-practice-2023.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/ich-e6-r3-good-clinical-practice-2023.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/ich-e6-r3-good-clinical-practice-2023
- Back to registry: Browse all 10,099 compliance nodes