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Cross-Framework Mapping

ICH E6(R3) - Good Clinical PracticevsISO 45001:2018

See exactly how ICH E6(R3) - Good Clinical Practice controls map to ISO 45001:2018. Pre-computed mappings, identified gaps, and coverage analysis.

7
Controls Mapped
2
Gaps Found
33%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ICH E6(R3) - Good Clinical Practice maps to ISO 45001:2018 with 33% coverage across 3 directly mapped controls. Analysis of 9 ICH E6(R3) - Good Clinical Practice controls identifies 6 compliance gaps — primarily concentrated in ICH E6 Data Mgmt + External Data + Regulatory.

Source: TheArtOfService Knowledge Graph | 9 controls analysed | 700 frameworks | 323K+ cross-framework mappings

Control Mappings

Showing 7 of 7 mapped controls across 3 domains. Sign up to explore all 323K+ mappings across 700 frameworks.

ICH E6 Annex 1 - Electronic Systems(5 mappings)

ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrityICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity5 targets
→10.2Risk reporting
→4.1Password Policy
→4.2Multi-Factor Authentication
→5.3Determining and Evaluating Audit Programme Risks
→7.1Cyber Incident Response Planning

ICH E6 Scope + Principles(1 mappings)

ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
→9.2Internal Audit

ICH E6 Sponsor + Quality Risk Mgmt(1 mappings)

ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight
→10.2Risk reporting

Related Comparisons

Other ICH E6(R3) - Good Clinical Practice comparisons

ICH E6(R3) - Good Clinical Practice vs Aged Care Quality Standards (Australia)5 mappingsICH E6(R3) - Good Clinical Practice vs FDA Quality Management System Regulation (QMSR)5 mappingsICH E6(R3) - Good Clinical Practice vs Florida Digital Bill of Rights (FDBR)5 mappingsICH E6(R3) - Good Clinical Practice vs TEFCA - Trusted Exchange Framework and Common Agreement4 mappingsICH E6(R3) - Good Clinical Practice vs GAMP 5 - Good Automated Manufacturing Practice4 mappingsICH E6(R3) - Good Clinical Practice vs IEC 60601-1 - Medical Electrical Equipment Safety4 mappingsICH E6(R3) - Good Clinical Practice vs COSO Internal Control - Integrated Framework (2013)3 mappingsICH E6(R3) - Good Clinical Practice vs HITECH Act3 mappings

Other ISO 45001:2018 comparisons

BRCGS Global Standard for Food Safety Issue 9 vs ISO 45001:20186 mappingsPIC/S Guide to Good Manufacturing Practice for Medicinal Products vs ISO 45001:20186 mappingsFDA Quality Management System Regulation (QMSR) vs ISO 45001:20186 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO 45001:20186 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs ISO 45001:20186 mappingsISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories vs ISO 45001:20186 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO 45001:20186 mappingsAS9100D - Aerospace Quality Management System vs ISO 45001:20186 mappings

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What are the key differences between ICH E6(R3) - Good Clinical Practice and ISO 45001:2018?

ICH E6(R3) - Good Clinical Practice has 9 controls across its framework, while ISO 45001:2018 covers 37 controls. Direct mapping analysis identifies 3 overlapping controls (33% coverage). The frameworks diverge most significantly in ICH E6 Data Mgmt + External Data + Regulatory, where 1 ICH E6(R3) - Good Clinical Practice controls have no direct ISO 45001:2018 equivalent.

How many controls map between ICH E6(R3) - Good Clinical Practice and ISO 45001:2018?

Of 9 total ICH E6(R3) - Good Clinical Practice controls, 3 map directly to ISO 45001:2018 controls — representing 33% coverage. The remaining 6 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ICH E6(R3) - Good Clinical Practice to ISO 45001:2018?

6 ICH E6(R3) - Good Clinical Practice controls have no direct equivalent in ISO 45001:2018. The highest concentration of gaps is in ICH E6 Data Mgmt + External Data + Regulatory with 1 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 ICH E6(R3) - Good Clinical Practice and ISO 45001:2018?

The domain with the highest gap count is ICH E6 Data Mgmt + External Data + Regulatory (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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