ISO/IEC 30111:2019vsICH E6(R3) - Good Clinical Practice
See exactly how ISO/IEC 30111:2019 controls map to ICH E6(R3) - Good Clinical Practice. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO/IEC 30111:2019 maps to ICH E6(R3) - Good Clinical Practice with 9% coverage across 3 directly mapped controls. Analysis of 34 ISO/IEC 30111:2019 controls identifies 36 compliance gaps — primarily concentrated in Clause 6: Vulnerability Handling Process.
Source: TheArtOfService Knowledge Graph | 34 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 1-4: Introduction(2 mappings)
Clause 5: Vulnerability Handling Policy and Organization(1 mappings)
Related Comparisons
Other ISO/IEC 30111:2019 comparisons
Other ICH E6(R3) - Good Clinical Practice comparisons
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What are the key differences between ISO/IEC 30111:2019 and ICH E6(R3) - Good Clinical Practice?
ISO/IEC 30111:2019 has 34 controls across its framework, while ICH E6(R3) - Good Clinical Practice covers 9 controls. Direct mapping analysis identifies 3 overlapping controls (9% coverage). The frameworks diverge most significantly in Clause 6: Vulnerability Handling Process, where 5 ISO/IEC 30111:2019 controls have no direct ICH E6(R3) - Good Clinical Practice equivalent.
How many controls map between ISO/IEC 30111:2019 and ICH E6(R3) - Good Clinical Practice?
Of 34 total ISO/IEC 30111:2019 controls, 3 map directly to ICH E6(R3) - Good Clinical Practice controls — representing 9% 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 30111:2019 to ICH E6(R3) - Good Clinical Practice?
36 ISO/IEC 30111:2019 controls have no direct equivalent in ICH E6(R3) - Good Clinical Practice. The highest concentration of gaps is in Clause 6: Vulnerability Handling Process 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 30111:2019 and ICH E6(R3) - Good Clinical Practice?
The domain with the highest gap count is Clause 6: Vulnerability Handling Process (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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