---
title: "CTR 536/2014 — EU Clinical Trials Regulation | QbD Group"
description: "The regulation harmonising clinical trial authorisation and supervision across the EU. It introduced a single submission through CTIS, coordinated asses..."
url: https://qbdgroup.com/en/knowledge-center/glossary/ctr-536-2014
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"CTR 536/2014 — EU Clinical Trials Regulation | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/ctr-536-2014"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# CTR 536/2014

EU Clinical Trials Regulation

Clinical

## Definition

The regulation harmonising clinical trial authorisation and supervision across the EU. It introduced a single submission through CTIS, coordinated assessment between member states, defined assessment timelines, and public transparency of trial information.

## Related terms

[GCPThe international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects, set out in ICH E6. Compliance protects participant rights and safety and makes trial data credible to regulators.](https://qbdgroup.com/en/knowledge-center/glossary/gcp)[CTISThe single EU portal and database for clinical trial applications under CTR 536/2014. Sponsors submit one dossier for all concerned member states and manage the full lifecycle there: authorisation, substantial modifications, safety reporting, and results.](https://qbdgroup.com/en/knowledge-center/glossary/ctis)[CTAThe application seeking authorisation to run a clinical trial in a given territory. It bundles the protocol, investigator's brochure, IMP dossier, informed consent documents, and site and investigator information for regulatory and ethics review.](https://qbdgroup.com/en/knowledge-center/glossary/cta)[CERThe MDR deliverable that documents the systematic appraisal of clinical data for a medical device. It weighs literature, clinical investigations, and post-market data against the intended purpose to confirm safety, performance, and an acceptable benefit-risk profile.](https://qbdgroup.com/en/knowledge-center/glossary/cer)[PMCFThe proactive collection and evaluation of clinical data from a CE-marked device in normal use, planned to confirm safety and performance, keep the benefit-risk determination current, and detect emerging risks or off-label use.](https://qbdgroup.com/en/knowledge-center/glossary/pmcf)[Investigator's BrochureThe compilation of clinical and non-clinical data on an investigational product that is relevant to its study in humans. It gives investigators the dosing, safety, and monitoring information they need and is updated as new data emerge.](https://qbdgroup.com/en/knowledge-center/glossary/investigators-brochure)

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