CTR Classification Guide
In all European Union Member States and the European Economic Area, the EU Clinical Trials Regulation (CTR 536/2014) applies to clinical trials involving medicinal products, including Advanced Therapy Medicinal Products (ATMPs) and vaccines. This free tool helps you determine whether your study qualifies as a clinical trial, a low-intervention clinical trial, or falls outside the scope of the Regulation.
Why did we develop this guide?
It can be difficult to determine whether a study involving a medicinal product
falls under the CTR, qualifies as a low-intervention clinical trial, or is outside the
scope of the CTR. To help with this, a free and easy-to-use CTR Classification
Guide has been developed.
Why is this guide special?
By answering just a few simple questions, the CTR Classification Guide will show
whether your study involving a medicinal product falls under the CTR, qualifies
as a low-intervention trial with fewer regulatory requirements, or is outside the
scope of the CTR. The result is provided as a downloadable PDF that you can save
and include in your study records.
Disclaimer
The CTR Classification Guide is intended for educational purposes only and is
based on Annex I of the European Commission’s CTR Q&A published in EudraLex
Volume 10. No rights can be derived from the results provided by this guide.
Based on annex I of the Q&A CTR published by European Commission on Eudralex volume 10
A user-friendly interface
A dated downloadable pdf output file