Clinical Trial Decision Tool
From January 31 2022 the EU Clinical Trials Regulation (CTR 536/2014) is applicable in all member states of the European Union and European Economic Area for clinical trials with medicinal products including Advanced Therapy Medicinal Products (ATMPs) and vaccines. This free tool helps you to determine whether your study is considered a clinical trial, a low-intervention clinical trial or is outside scope of the regulation.
Why did we develop this tool?
Determining whether your study with a medicinal product falls within the scope of the CTR, is a low-intervention trial or does not fall within the scope of the CTR, may not be easy. To assist you in this process, this free and user-friendly Clinical Trial Decision Tool has been developed jointly by Paul Janssen Futurelab and the Central Committee on Research Involving Human Subjects (CCMO, the Competent Authority for clinical trials in the Netherlands).
Why is this tool special?
By just answering a small set of questions, the Clinical Trial Decision tool will indicate whether your study with a medicinal product falls within the scope of the CTR, is a low-intervention trial for which less stringent rules applies, or does not fall within the scope of the CTR. The output is a pdf file that you can download and archive in your dossier.
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