EU Clinical Trials Regulation (CTR 536/2014)
Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Replaces the Clinical Trials Directive 2001/20/EC. Establishes a harmonised framework for authorising and supervising clinical trials across the European Union through the Clinical Trials Information System (CTIS). The regulation aims to simplify and streamline the assessment and supervision of clinical trials, ensuring a high level of public health protection and transparency. It became fully applicable on 31 January 2023.
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Framework Domains (4)
Chapter II — Application and Authorisation
Clinical trial application, assessment, and authorisation procedures
| Code | Title |
|---|---|
| CTR-II-01 | Single Application via CTIS |
| CTR-II-02 | Part I Assessment (Scientific) |
| CTR-II-03 | Part II Assessment (National) |
| CTR-II-04 | Tacit Authorisation |
| CTR-II-05 | Substantial Modification Procedure |
Chapter III — Subject Protection
Informed consent, protection of vulnerable subjects, and insurance/indemnification
| Code | Title |
|---|---|
| CTR-III-01 | Informed Consent Requirements |
| CTR-III-02 | Protection of Minors |
| CTR-III-03 | Protection of Incapacitated Subjects |
| CTR-III-04 | Damage Compensation and Insurance |
Chapter V-VII — Safety Reporting and GMP
Safety reporting, manufacturing, and labelling of investigational medicinal products
| Code | Title |
|---|---|
| CTR-V-01 | Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting |
| CTR-V-02 | Annual Safety Report |
| CTR-VI-01 | GMP for Investigational Medicinal Products |
| CTR-VII-01 | Labelling of Investigational Medicinal Products |
Chapter VIII-XI — Supervision and Transparency
Inspections, transparency, data protection, and enforcement
| Code | Title |
|---|---|
| CTR-IX-01 | EU Database and Transparency |
| CTR-VIII-01 | Inspections by Member States |
| CTR-X-01 | Data Protection Compliance |
| CTR-XI-01 | Penalties for Non-Compliance |
Your Compliance Coverage
If you comply with EU Clinical Trials Regulation (CTR 536/2014), you already cover:
Connecticut Data Privacy Act (CTDPA)
29%
5 controls mapped
Compare →Florida Digital Bill of Rights (FDBR)
29%
5 controls mapped
Compare →Australia My Health Records Act 2012
29%
5 controls mapped
Compare →+ 563 more: IEC 60601-1 — Medical Electrical Equipment Safety (24%), Angola Personal Data Protection Law (Law No. 22/11) (24%)
See all 566 mapped frameworks ↓Maps to 566 other frameworks
Frequently Asked Questions
What is EU Clinical Trials Regulation (CTR 536/2014)?
EU Clinical Trials Regulation (CTR 536/2014) is a compliance framework from European Union with 4 domains and 17 controls. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Replaces the Clinical Trials Directive 2001/20/EC. Establishes a harmonised framework for authorising and supervising clinical trials across the European Union through the Clinical Trials Information System (CTIS). The regulation aims to simplify and streamline the assessment and supervision of clinical trials, ensuring a high level of public health protection and transparency. It became fully applicable on 31 January 2023. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does EU Clinical Trials Regulation (CTR 536/2014) have?
EU Clinical Trials Regulation (CTR 536/2014) has 17 controls organised across 4 domains. The largest domains are Chapter II — Application and Authorisation (5 controls), Chapter III — Subject Protection (4 controls), Chapter V-VII — Safety Reporting and GMP (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does EU Clinical Trials Regulation (CTR 536/2014) map to?
EU Clinical Trials Regulation (CTR 536/2014) maps to 566 other compliance frameworks. The top mapping partners are Connecticut Data Privacy Act (CTDPA) (29% coverage), Florida Digital Bill of Rights (FDBR) (29% coverage), Australia My Health Records Act 2012 (29% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with EU Clinical Trials Regulation (CTR 536/2014) compliance?
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