EU Clinical Trials Regulation (CTR 536/2014)
Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) harmonises the authorisation and conduct of clinical trials on medicinal products for human use across the EU/EEA. It repealed Directive 2001/20/EC and came into application on 31 January 2022 following the go-live of the Clinical Trials Information System (CTIS), with mandatory CTIS use from 31 January 2023 (new trials) and full transition by 31 January 2025 (legacy 2001/20/EC trials). Key features: a single EU-wide application through CTIS; harmonised Part I (scientific) and Part II (national / ethics) assessment with one Reporting Member State; substantial modification procedure; subject protection and informed consent rules (with specific provisions for incapacitated subjects, minors, pregnant/breastfeeding women, emergency trials); safety reporting (SUSAR via EudraVigilance, annual safety reports, serious breach reporting); compliance with the protocol and Good Clinical Practice; risk-based monitoring; trial master file and 25-year retention; manufacturing/import authorisation for investigational medicinal products (IMPs) with qualified person responsibility; harmonised labelling; sponsor and investigator obligations; damage compensation systems by Member States; Member State inspections and Union controls; the EU portal and EU database (CTIS) with public-transparency layer; the Clinical Trials Coordination and Advisory Group (CTAG); fees; data protection (alignment with the GDPR for clinical-trial data); penalties.
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Framework Domains (8)
CTR - Application Dossier (Ch IV)
| Code | Title |
|---|---|
| CTR-Art.25_26_27 | Application dossier and language requirements (Articles 25-27) |
CTR - Authorisation Procedure and Substantial Modifications (Ch II-III)
| Code | Title |
|---|---|
| CTR-Art.10 | Specific considerations for vulnerable populations (Article 10) |
| CTR-Art.15_16_17 | Substantial modification procedure (Articles 15-17) |
| CTR-Art.4_5 | Prior authorisation and submission of application (Articles 4-5) |
| CTR-Art.6_7 | Part I and Part II assessment (Articles 6-7) |
| CTR-Art.8 | Decision on the clinical trial (Article 8) |
CTR - CTIS, Cooperation and Final Provisions (Ch XIV-XIX)
| Code | Title |
|---|---|
| CTR-Art.80_81_82 | EU portal, EU database and functionality (Articles 80-82) - CTIS |
| CTR-Art.83_84_85 | National contact points, Agency support and Clinical Trials Coordination and Advisory Group (Articles 83-85) |
| CTR-Art.93 | Data protection (Article 93) |
| CTR-Art.94 | Penalties (Article 94) |
CTR - Conduct, Manufacturing and Labelling (Ch VIII-X)
| Code | Title |
|---|---|
| CTR-Art.47 | Compliance with the protocol and Good Clinical Practice (Article 47) |
| CTR-Art.48 | Monitoring (Article 48) |
| CTR-Art.52 | Reporting of serious breaches (Article 52) |
| CTR-Art.57_58 | Clinical trial master file and archiving (Articles 57-58) |
| CTR-Art.61_62_63 | Manufacturing and import of IMPs and the qualified person (Articles 61-63) |
| CTR-Art.66_67_68_69 | Labelling of investigational medicinal products (Articles 66-69) |
CTR - General Provisions (Ch I)
| Code | Title |
|---|---|
| CTR-Art.1 | Scope (Article 1) |
| CTR-Art.2 | Definitions (Article 2) |
| CTR-Art.3 | General principle (Article 3) |
CTR - Sponsor, Damage Compensation and Supervision (Ch XI-XIII)
| Code | Title |
|---|---|
| CTR-Art.71_72_73_74 | Sponsor, co-sponsorship, principal investigator and legal representative (Articles 71-74) |
| CTR-Art.76 | Damage compensation (Article 76) |
| CTR-Art.77_78_79 | Corrective measures, Member State inspections and Union controls (Articles 77-79) |
CTR - Start, End and Safety Reporting (Ch VI-VII)
| Code | Title |
|---|---|
| CTR-Art.36_37 | Start and end of trial notifications (Articles 36-37) |
| CTR-Art.38 | Temporary halt or early termination for subject safety (Article 38) |
| CTR-Art.41_42 | Adverse-event and SUSAR reporting (Articles 41-42) |
| CTR-Art.43 | Annual safety reporting (Article 43) |
CTR - Subject Protection and Informed Consent (Ch V)
| Code | Title |
|---|---|
| CTR-Art.28 | General rules on subject protection (Article 28) |
| CTR-Art.29 | Informed consent (Article 29) |
| CTR-Art.31_32 | Trials on incapacitated subjects and minors (Articles 31-32) |
| CTR-Art.33_34_35 | Pregnant/breastfeeding subjects, additional national measures, emergency trials (Articles 33-35) |
Your Compliance Coverage
If you comply with EU Clinical Trials Regulation (CTR 536/2014), you already cover:
ICH E6(R3) - Good Clinical Practice
27%
8 controls mapped
Compare →EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
13%
4 controls mapped
Compare →GDPR
13%
4 controls mapped
Compare →+ 1 more: EU Medical Devices Regulation (MDR 2017/745) (7%)
See all 4 mapped frameworks ↓Maps to 4 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 8 domains and 30 controls. Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) harmonises the authorisation and conduct of clinical trials on medicinal products for human use across the EU/EEA. It repealed Directive 2001/20/EC and came into application on 31 January 2022 following the go-live of the Clinical Trials Information System (CTIS), with mandatory CTIS use from 31 January 2023 (new trials) and full transition by 31 January 2025 (legacy 2001/20/EC trials). Key features: a single EU-wide application through CTIS; harmonised Part I (scientific) and Part II (national / ethics) assessment with one Reporting Member State; substantial modification procedure; subject protection and informed consent rules (with specific provisions for incapacitated subjects, minors, pregnant/breastfeeding women, emergency trials); safety reporting (SUSAR via EudraVigilance, annual safety reports, serious breach reporting); compliance with the protocol and Good Clinical Practice; risk-based monitoring; trial master file and 25-year retention; manufacturing/import authorisation for investigational medicinal products (IMPs) with qualified person responsibility; harmonised labelling; sponsor and investigator obligations; damage compensation systems by Member States; Member State inspections and Union controls; the EU portal and EU database (CTIS) with public-transparency layer; the Clinical Trials Coordination and Advisory Group (CTAG); fees; data protection (alignment with the GDPR for clinical-trial data); penalties. 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 30 controls organised across 8 domains. The largest domains are CTR - Conduct, Manufacturing and Labelling (Ch VIII-X) (6 controls), CTR - Authorisation Procedure and Substantial Modifications (Ch II-III) (5 controls), CTR - CTIS, Cooperation and Final Provisions (Ch XIV-XIX) (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 4 other compliance frameworks. The top mapping partners are ICH E6(R3) - Good Clinical Practice (27% coverage), EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (13% coverage), GDPR (13% 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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