Cross-Framework Mapping

ICH E6(R3) - Good Clinical PracticevsEU Clinical Trials Regulation (CTR 536/2014)

Name: ICH E6(R3) - Good Clinical Practice to EU Clinical Trials Regulation (CTR 536/2014) Control Mapping Dataset
Creator: TheArtOfService

See exactly how ICH E6(R3) - Good Clinical Practice controls map to EU Clinical Trials Regulation (CTR 536/2014). Pre-computed mappings, identified gaps, and coverage analysis.

Controls Mapped

Gaps Found

33%

Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ICH E6(R3) - Good Clinical Practice maps to EU Clinical Trials Regulation (CTR 536/2014) 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 | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 13 of 13 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

ICH E6 Annex 1 - Electronic Systems(8 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 Integrity8 targets

→CTR-Art.28General rules on subject protection (Article 28)

→CTR-Art.29Informed consent (Article 29)

→CTR-Art.41_42Adverse-event and SUSAR reporting (Articles 41-42)

→CTR-Art.43Annual safety reporting (Article 43)

→CTR-Art.47Compliance with the protocol and Good Clinical Practice (Article 47)

→CTR-Art.48Monitoring (Article 48)

→CTR-Art.57_58Clinical trial master file and archiving (Articles 57-58)

→CTR-Art.80_81_82EU portal, EU database and functionality (Articles 80-82) - CTIS

ICH E6 IRB/IEC + Informed Consent(4 mappings)

ICH-E6-IRB-IEC-EthicsCommittee-InformedConsent-VulnerableICH E6 Section 3 - Institutional Review Board (IRB) + Independent Ethics Committee (IEC) + Informed Consent + Vulnerable Populations4 targets

→CTR-Art.41_42Adverse-event and SUSAR reporting (Articles 41-42)

→CTR-Art.43Annual safety reporting (Article 43)

→CTR-Art.47Compliance with the protocol and Good Clinical Practice (Article 47)

→CTR-Art.48Monitoring (Article 48)

ICH E6 Investigator(1 mappings)

ICH-E6-Investigator-Qualifications-Resources-Communication-SafetyReportingICH E6 Section 4 - Investigator + Qualifications + Resources + Communication + Safety Reporting + Source Document Verification

→CTR-Art.57_58Clinical trial master file and archiving (Articles 57-58)

Related Comparisons

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Other EU Clinical Trials Regulation (CTR 536/2014) comparisons

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs EU Clinical Trials Regulation (CTR 536/2014)4 mappings GDPR vs EU Clinical Trials Regulation (CTR 536/2014)4 mappings EU Medical Devices Regulation (MDR 2017/745) vs EU Clinical Trials Regulation (CTR 536/2014)2 mappings

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What are the key differences between ICH E6(R3) - Good Clinical Practice and EU Clinical Trials Regulation (CTR 536/2014)?

ICH E6(R3) - Good Clinical Practice has 9 controls across its framework, while EU Clinical Trials Regulation (CTR 536/2014) covers 30 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 EU Clinical Trials Regulation (CTR 536/2014) equivalent.

How many controls map between ICH E6(R3) - Good Clinical Practice and EU Clinical Trials Regulation (CTR 536/2014)?

Of 9 total ICH E6(R3) - Good Clinical Practice controls, 3 map directly to EU Clinical Trials Regulation (CTR 536/2014) 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 EU Clinical Trials Regulation (CTR 536/2014)?

6 ICH E6(R3) - Good Clinical Practice controls have no direct equivalent in EU Clinical Trials Regulation (CTR 536/2014). 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 EU Clinical Trials Regulation (CTR 536/2014)?

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

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.