OtherInternational (ICH)
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
Compare ICH E6(R3) — Good Clinical Practice
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ICH E6(R3) — Good Clinical Practice by Industry
ICH E6(R3) — Good Clinical Practice for Healthcare→ICH E6(R3) — Good Clinical Practice for Financial Services→ICH E6(R3) — Good Clinical Practice for Technology→ICH E6(R3) — Good Clinical Practice for Government→ICH E6(R3) — Good Clinical Practice for Manufacturing→ICH E6(R3) — Good Clinical Practice for Energy→ICH E6(R3) — Good Clinical Practice for Retail→ICH E6(R3) — Good Clinical Practice for Education→
ICH E6(R3) — Good Clinical Practice by Role
ICH E6(R3) — Good Clinical Practice for CISOs→ICH E6(R3) — Good Clinical Practice for Compliance Officers→ICH E6(R3) — Good Clinical Practice for Risk Managers→ICH E6(R3) — Good Clinical Practice for IT Directors→ICH E6(R3) — Good Clinical Practice for DPOs→ICH E6(R3) — Good Clinical Practice for Auditors→
Frequently Asked Questions
What is ICH E6(R3)?
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..
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.
How ready are you for ICH E6(R3) — Good Clinical Practice?
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