ICH E6 Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing + conducting + recording + reporting trials that involve participation of human subjects. Developed by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - founded 1990 + tripartite (regulators + industry) global standardisation body. ICH E6 history: E6 original 1995-1996; E6(R1) post-Step 4 editorial corrections 2009; E6(R2) Integrated Addendum (Step 4 dated 9 November 2016) - introduced quality risk management + risk-based monitoring + electronic systems; **E6(R3) Step 4 finalised 6 January 2025** - SUPERSEDES E6(R2) - completely restructured with: 5 Principles (P1-P5) emphasising risk-based + proportionate + decentralised + electronic + data integrity by design; Glossary (Section 2); IRB/IEC (Section 3); Investigator (Section 4); Sponsor (Section 5); Data Governance (Section 6); Clinical Study Report (CSR); 2 Annexes - Annex 1 Computer Systems + Annex 2 Decentralised Elements. R3 implementation: FDA + EMA + PMDA + Health Canada + Swissmedic + ANVISA + WHO + national regulators globally; staged regulatory adoption; transition from R2 ongoing 2025-2027. R3 emphasises: stakeholder cooperation + risk proportionality + critical-to-quality + technology-agnostic + decentralised trials + investigator and sponsor flexibility + participant-centric + transparent communication + lifecycle approach. Mandatory for marketing authorisation studies + Investigational New Drug (IND) submissions in ICH regions. Coordinates with FDA 21 CFR Part 50 (Informed Consent) + Part 56 (IRBs) + Part 312 (IND) + Part 314 (NDA) + Part 11 (Electronic Records and Signatures) + EMA + EU Clinical Trials Regulation 536/2014 (CTR) + PMDA + WHO Operational Guidelines + Declaration of Helsinki 2024 + ICH E8 (General Considerations) + ICH E9 (Statistical) + ICH E2A (Safety Reporting) + ALCOA+ Data Integrity principles. ICH E6 + R3 + Principles + Risk-Based + Decentralised + R2 history applies.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.