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.
hy is this guide special?
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