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Cross-Framework Mapping

EU Clinical Trials Regulation (CTR 536/2014)vsGDPR

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

9
Controls Mapped
21
Gaps Found
13%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EU Clinical Trials Regulation (CTR 536/2014) maps to GDPR with 13% coverage across 4 directly mapped controls. Analysis of 30 EU Clinical Trials Regulation (CTR 536/2014) controls identifies 26 compliance gaps — primarily concentrated in CTR - Conduct, Manufacturing and Labelling (Ch VIII-X).

Source: TheArtOfService Knowledge Graph | 30 controls analysed | 700 frameworks | 323K+ cross-framework mappings

Control Mappings

Showing 9 of 9 mapped controls across 2 domains. Sign up to explore all 323K+ mappings across 700 frameworks.

CTR - Subject Protection and Informed Consent (Ch V)(4 mappings)

CTR-Art.28General rules on subject protection (Article 28)
→GDPR-Art.6Lawfulness of processing
CTR-Art.29Informed consent (Article 29)3 targets
→GDPR-Art.6Lawfulness of processing
→GDPR-Art.7Conditions for consent
→GDPR-Art.9Processing of special categories of personal data

CTR - CTIS, Cooperation and Final Provisions (Ch XIV-XIX)(5 mappings)

CTR-Art.80_81_82EU portal, EU database and functionality (Articles 80-82) - CTIS
→GDPR-Art.32Security of processing
CTR-Art.93Data protection (Article 93)4 targets
→GDPR-Art.32Security of processing
→GDPR-Art.5Principles relating to processing of personal data
→GDPR-Art.6Lawfulness of processing
→GDPR-Art.9Processing of special categories of personal data

Related Comparisons

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

EU Clinical Trials Regulation (CTR 536/2014) vs ICH E6(R3) - Good Clinical Practice8 mappingsEU Clinical Trials Regulation (CTR 536/2014) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)4 mappingsEU Clinical Trials Regulation (CTR 536/2014) vs EU Medical Devices Regulation (MDR 2017/745)2 mappings

Other GDPR comparisons

Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL) vs GDPR22 mappingsAICPA Privacy Management Framework (PMF) vs GDPR20 mappingsAlbania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014) vs GDPR18 mappingsAPPI vs GDPR18 mappingsISO 27001:2022 vs GDPR16 mappingsChina Personal Information Protection Law (PIPL) vs GDPR15 mappingsAustralian Privacy Principles (APPs) vs GDPR14 mappingsArmenia Law on Protection of Personal Data (2015) vs GDPR14 mappings

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What are the key differences between EU Clinical Trials Regulation (CTR 536/2014) and GDPR?

EU Clinical Trials Regulation (CTR 536/2014) has 30 controls across its framework, while GDPR covers 27 controls. Direct mapping analysis identifies 4 overlapping controls (13% coverage). The frameworks diverge most significantly in CTR - Conduct, Manufacturing and Labelling (Ch VIII-X), where 6 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct GDPR equivalent.

How many controls map between EU Clinical Trials Regulation (CTR 536/2014) and GDPR?

Of 30 total EU Clinical Trials Regulation (CTR 536/2014) controls, 4 map directly to GDPR controls — representing 13% coverage. The remaining 26 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping EU Clinical Trials Regulation (CTR 536/2014) to GDPR?

26 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct equivalent in GDPR. The highest concentration of gaps is in CTR - Conduct, Manufacturing and Labelling (Ch VIII-X) with 6 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 EU Clinical Trials Regulation (CTR 536/2014) and GDPR?

The domain with the highest gap count is CTR - Conduct, Manufacturing and Labelling (Ch VIII-X) (6 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.