How many controls does ICH E6(R2) Good Clinical Practice have?

ICH E6(R2) Good Clinical Practice contains 22 controls organized across 7 domains.

Where does ICH E6(R2) Good Clinical Practice apply?

ICH E6(R2) Good Clinical Practice is applicable in International (ICH). Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does ICH E6(R2) Good Clinical Practice map to?

ICH E6(R2) Good Clinical Practice has control-to-control mappings with 498 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with ICH E6(R2) Good Clinical Practice 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(R2) Good Clinical Practice — Data Integrity and Electronic Systems

ICH E6(R2) (International Council for Harmonisation, 2016, with R3 under development) establishes international ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials. The guideline includes specific provisions for electronic systems, data integrity, and computerised systems used in clinical trials.

Domains

Section 8 - Essential Documents

Section 6 - Clinical Trial Protocol and Amendments

Section 5 - Sponsor

Section 4 - Investigator

Section 3 - Institutional Review Board / Independent Ethics Committee (IRB/IEC)

Frequently Asked Questions

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