Cross-Framework Mapping

EU Clinical Trials Regulation (CTR 536/2014)vsAustralia NHMRC National Statement on Ethical Conduct in Human Research

See exactly how EU Clinical Trials Regulation (CTR 536/2014) controls map to Australia NHMRC National Statement on Ethical Conduct in Human Research. Pre-computed mappings, identified gaps, and coverage analysis.

6
Controls Mapped
11
Gaps Found
24%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EU Clinical Trials Regulation (CTR 536/2014) maps to Australia NHMRC National Statement on Ethical Conduct in Human Research with 24% coverage across 4 directly mapped controls. Analysis of 17 EU Clinical Trials Regulation (CTR 536/2014) controls identifies 13 compliance gaps — primarily concentrated in Chapter III — Subject Protection.

Source: TheArtOfService Knowledge Graph | 17 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 6 of 6 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Chapter II — Application and Authorisation(4 mappings)

CTR-II-01Single Application via CTIS
NHMRC-11Interventional Research
CTR-II-02Part I Assessment (Scientific)
NHMRC-11Interventional Research
CTR-II-05Substantial Modification Procedure2 targets
Art. 17Governance Structure
DMF-1.2Roles and Responsibilities

Chapter VIII-XI — Supervision and Transparency(2 mappings)

CTR-X-01Data Protection Compliance2 targets
Art. 19Consent Management Controls
NHMRC-11Interventional Research

Related Comparisons

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

Other Australia NHMRC National Statement on Ethical Conduct in Human Research comparisons

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What are the key differences between EU Clinical Trials Regulation (CTR 536/2014) and Australia NHMRC National Statement on Ethical Conduct in Human Research?

EU Clinical Trials Regulation (CTR 536/2014) has 17 controls across its framework, while Australia NHMRC National Statement on Ethical Conduct in Human Research covers 25 controls. Direct mapping analysis identifies 4 overlapping controls (24% coverage). The frameworks diverge most significantly in Chapter III — Subject Protection, where 4 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct Australia NHMRC National Statement on Ethical Conduct in Human Research equivalent.

How many controls map between EU Clinical Trials Regulation (CTR 536/2014) and Australia NHMRC National Statement on Ethical Conduct in Human Research?

Of 17 total EU Clinical Trials Regulation (CTR 536/2014) controls, 4 map directly to Australia NHMRC National Statement on Ethical Conduct in Human Research controls — representing 24% coverage. The remaining 13 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 Australia NHMRC National Statement on Ethical Conduct in Human Research?

13 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct equivalent in Australia NHMRC National Statement on Ethical Conduct in Human Research. The highest concentration of gaps is in Chapter III — Subject Protection with 4 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 Australia NHMRC National Statement on Ethical Conduct in Human Research?

The domain with the highest gap count is Chapter III — Subject Protection (4 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.