Cross-Framework Mapping

ICH E6(R3) - Good Clinical PracticevsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

See exactly how ICH E6(R3) - Good Clinical Practice controls map to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. Pre-computed mappings, identified gaps, and coverage analysis.

8
Controls Mapped
1
Gaps Found
33%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ICH E6(R3) - Good Clinical Practice maps to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements 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 | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 8 of 8 mapped controls across 3 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

ICH E6 Annex 1 - Electronic Systems(4 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 Integrity4 targets
3.1Physical Security
3.2Establish and Maintain a Data Inventory
3.3.1Audit Record Creation
3.4Enforce Data Retention

ICH E6 Scope + Principles(3 mappings)

ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation3 targets
3.16System and Services Acquisition
3.17Supply Chain Risk Management
3.3Configure Data Access Control Lists

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
3.1Physical Security

Related Comparisons

Other ICH E6(R3) - Good Clinical Practice comparisons

Other NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements comparisons

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What are the key differences between ICH E6(R3) - Good Clinical Practice and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

ICH E6(R3) - Good Clinical Practice has 9 controls across its framework, while NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements covers 35 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements equivalent.

How many controls map between ICH E6(R3) - Good Clinical Practice and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

Of 9 total ICH E6(R3) - Good Clinical Practice controls, 3 map directly to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

6 ICH E6(R3) - Good Clinical Practice controls have no direct equivalent in NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

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.

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.