OtherInternational (ICH)
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)
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ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems by Industry
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Healthcare→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Financial Services→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Technology→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Government→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Manufacturing→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Energy→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Retail→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Education→
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems by Role
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for CISOs→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Compliance Officers→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Risk Managers→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for IT Directors→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for DPOs→ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems for Auditors→
Frequently Asked Questions
What is ICH E6(R2) Good Clinical Practice?
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.
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.
How ready are you for ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems?
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