Cross-Framework Mapping

ISO/IEC 27400:2022vsICH E6(R3) - Good Clinical Practice

See exactly how ISO/IEC 27400:2022 controls map to ICH E6(R3) - Good Clinical Practice. Pre-computed mappings, identified gaps, and coverage analysis.

6
Controls Mapped
26
Gaps Found
16%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27400:2022 maps to ICH E6(R3) - Good Clinical Practice with 16% coverage across 6 directly mapped controls. Analysis of 32 ISO/IEC 27400:2022 controls identifies 36 compliance gaps — primarily concentrated in Clause 6: IoT Security Controls.

Source: TheArtOfService Knowledge Graph | 32 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 6 of 6 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 1-4: Introduction and Framework(3 mappings)

27011-1Scope
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
27011-3Terms and definitions
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
27400-3Terms and definitions
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation

Network(1 mappings)

27400-7.1Network Security for IoT
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

Clause 7: IoT Privacy Controls(2 mappings)

27400-7.1Network Security for IoT
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight
27400-7.4Data retention and deletion
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

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What are the key differences between ISO/IEC 27400:2022 and ICH E6(R3) - Good Clinical Practice?

ISO/IEC 27400:2022 has 32 controls across its framework, while ICH E6(R3) - Good Clinical Practice covers 9 controls. Direct mapping analysis identifies 6 overlapping controls (16% coverage). The frameworks diverge most significantly in Clause 6: IoT Security Controls, where 5 ISO/IEC 27400:2022 controls have no direct ICH E6(R3) - Good Clinical Practice equivalent.

How many controls map between ISO/IEC 27400:2022 and ICH E6(R3) - Good Clinical Practice?

Of 32 total ISO/IEC 27400:2022 controls, 6 map directly to ICH E6(R3) - Good Clinical Practice controls — representing 16% coverage. The remaining 36 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 27400:2022 to ICH E6(R3) - Good Clinical Practice?

36 ISO/IEC 27400:2022 controls have no direct equivalent in ICH E6(R3) - Good Clinical Practice. The highest concentration of gaps is in Clause 6: IoT Security Controls with 5 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between ISO/IEC 27400:2022 and ICH E6(R3) - Good Clinical Practice?

The domain with the highest gap count is Clause 6: IoT Security Controls (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.