How many controls does ICH E6(R3) have?

ICH E6(R3) contains 17 controls organized across 7 domains.

Where does ICH E6(R3) apply?

ICH E6(R3) is applicable in International (ICH). Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does ICH E6(R3) map to?

ICH E6(R3) has control-to-control mappings with 539 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with ICH E6(R3) compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

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..

Domains

Annex 2 - Non-Traditional Interventional Clinical Trials

Annex 1 - Data Governance

Annex 1 - Sponsor Responsibilities

Annex 1 - Investigator Responsibilities

Annex 1 - IRB/IEC Responsibilities

Frequently Asked Questions

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