ICH E6(R3) - Good Clinical Practice
What is ICH E6(R3) - Good Clinical Practice?
ICH E6(R3) Good Clinical Practice (GCP) is the international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The R3 revision (adopted 2023) modernizes GCP for technology-enabled clinical trials, introduces a quality-by-design approach, and addresses decentralized trials, electronic data, and risk-proportionate monitoring.. It comprises 9 controls organised across 9 domains, and applies in International (ICH).
How ICH E6(R3) - Good Clinical Practice maps to other frameworks
All 9 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 9 domains ICH E6(R3) - Good Clinical Practice groups its controls into
Where ICH E6(R3) - Good Clinical Practice overlaps with the standards you already hold
Where to get trained on ICH E6(R3) - Good Clinical Practice
2 courses in the catalogue cover ICH E6(R3) - Good Clinical Practice directly. Each is self-paced, includes the downloadable toolkit and the implementation playbook, and carries a certificate of completion.
What ICH E6(R3) - Good Clinical Practice means in your sector
What ICH E6(R3) - Good Clinical Practice means for your job
Questions people ask about ICH E6(R3) - Good Clinical Practice
What is ICH E6(R3) - Good Clinical Practice?
How many controls does ICH E6(R3) - Good Clinical Practice have?
Where does ICH E6(R3) - Good Clinical Practice apply?
What frameworks does ICH E6(R3) - Good Clinical Practice map to?
How do I get started with ICH E6(R3) - Good Clinical Practice compliance?
Query ICH E6(R3) - Good Clinical Practice programmatically
ICH E6(R3) - Good Clinical Practice, its 9 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
ICH E6(R3) - Good Clinical Practice API reference and MCP config →What ICH E6(R3) - Good Clinical Practice requires, control by control
Each page carries the requirement text for one ICH E6(R3) - Good Clinical Practice control and what an assessor expects to see as evidence.
- ICH-E6-ANNEX1-ELECTRONICSYSTEMS-CSV-ESIG-AUDIT-ALCOA-DATAINTEGRITY ICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity
- ICH-E6-ANNEX2-DECENTRALISEDCLINICALTRIALS-DCT-ECONSENT-REMOTE-WEARABLES ICH E6(R3) Annex 2 - Decentralised Clinical Trial (DCT) Elements + eConsent + Remote Monitoring + Wearables + Real-World Evidence
- ICH-E6-ESSENTIALDOCS-TMF-ETMF-ARCHIVERETENTION-ICH-SECTION8 ICH E6 Section 8 - Essential Documents + Trial Master File (TMF) + eTMF + Archive + Retention
- ICH-E6-INVESTIGATOR-QUALIFICATIONS-RESOURCES-COMMUNICATION-SAFETYREPORTING ICH E6 Section 4 - Investigator + Qualifications + Resources + Communication + Safety Reporting + Source Document Verification
- ICH-E6-IRB-IEC-ETHICSCOMMITTEE-INFORMEDCONSENT-VULNERABLE ICH E6 Section 3 - Institutional Review Board (IRB) + Independent Ethics Committee (IEC) + Informed Consent + Vulnerable Populations
- ICH-E6-SCOPE-PRINCIPLES-R3-2025-RISK-BASED-DECENTRALISEDCLINICAL ICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
- ICH-E6-SPONSOR-QUALITYRISKMGMT-MONITORING-CRO-VENDOR ICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight
How ready are you for ICH E6(R3) - Good Clinical Practice?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.