EU Clinical Trials Regulation (CTR 536/2014)vsAustralia My Health Records Act 2012
See exactly how EU Clinical Trials Regulation (CTR 536/2014) controls map to Australia My Health Records Act 2012. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU Clinical Trials Regulation (CTR 536/2014) maps to Australia My Health Records Act 2012 with 29% coverage across 5 directly mapped controls. Analysis of 17 EU Clinical Trials Regulation (CTR 536/2014) controls identifies 12 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 16 of 16 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Chapter II — Application and Authorisation(10 mappings)
Chapter V-VII — Safety Reporting and GMP(1 mappings)
Chapter VIII-XI — Supervision and Transparency(5 mappings)
Related Comparisons
Other EU Clinical Trials Regulation (CTR 536/2014) comparisons
Other Australia My Health Records Act 2012 comparisons
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What are the key differences between EU Clinical Trials Regulation (CTR 536/2014) and Australia My Health Records Act 2012?
EU Clinical Trials Regulation (CTR 536/2014) has 17 controls across its framework, while Australia My Health Records Act 2012 covers 22 controls. Direct mapping analysis identifies 5 overlapping controls (29% 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 My Health Records Act 2012 equivalent.
How many controls map between EU Clinical Trials Regulation (CTR 536/2014) and Australia My Health Records Act 2012?
Of 17 total EU Clinical Trials Regulation (CTR 536/2014) controls, 5 map directly to Australia My Health Records Act 2012 controls — representing 29% coverage. The remaining 12 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 My Health Records Act 2012?
12 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct equivalent in Australia My Health Records Act 2012. 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 My Health Records Act 2012?
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.
Related Resources
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