CTIS — EU Clinical Trials Information System

Overview

The Clinical Trials Information System (CTIS) is the EU’s centralised portal for clinical trial authorisation, supervision, and transparency under EU Clinical Trials Regulation 536/2014. The European Medicines Agency (EMA) operates it, replacing the previous EudraCT system. CTIS became the mandatory registration and submission platform for interventional trials of medicinal products in the EU and EEA from 31 January 2023. It does not cover medical device trials, governed separately under the EU Medical Device Regulation, or purely observational studies, which have no equivalent EU-wide regulation and are instead governed by national law and GDPR.

What CTIS Provides

For Sponsors and Investigators

• A single submission portal covering all EU/EEA member states simultaneously
• Coordinated assessment involving the reference member state (RMS) and concerned member states (CMS)
• Ethics committee (EC) review linked to the single application workflow
• Lifecycle management: protocol amendments, substantial modifications, safety reporting
• Results submission: end-of-trial notifications, clinical study reports (layperson summaries required)

For the Public

• A public transparency portal (https://euclinicaltrials.eu) providing searchable access to trial information including protocols, results, and layperson summaries
• Results data published within 12 months of trial completion
• Adverse event summaries and clinical study reports published for all trials

Relationship to ClinicalTrials.gov

CTIS and ClinicalTrials.gov serve the same conceptual role, a public trial registry and results database, but they are independent systems with different jurisdictions and data models. Academic trials at French and European sites typically register in both. CTIS registration is required under EU law, while ClinicalTrials.gov registration is required by ICMJE journals and increasingly by funders. EMA has published a harmonisation roadmap aligning the two systems’ data models, though full interoperability is still in progress.

Data Standards

CTIS data is structured around the EU CTR protocol template, which is aligned with:

• CDISC for protocol metadata (CDASH and SDTM conventions)
• HL7 FHIR for programmatic data access (FHIR-based APIs in development)
• MedDRA for adverse event coding in safety reports
• ICD-10 and ICD-11 for condition coding in indication fields
• MeSH for condition and intervention terminology

Connections

• relatedTo: ClinicalTrials.gov (the US equivalent registry, academic European trials typically register in both)
• implements: CDISC
• implements: MedDRA
• implements: ICD-10
• implements: HL7 FHIR

Resources

• https://euclinicaltrials.eu (CTIS public portal, trial search and results)
• https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-regulation (EMA CTIS overview)
• https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system-ctis-training-support (EMA CTIS training)
• https://www.clinicaltrialsregister.eu (EudraCT legacy, now redirects to CTIS)