Research with a medicinal product

From 31 January 2023, all ongoing research with medicinal products must comply with the Clinical Trial Regulation. More information is available at Clinical trials with medicinal products (CTR).

It is not always easy to clearly define research with a medicinal product. The Clinical Trial Decision Tool, developed jointly by Paul Janssen Futurelab and CCMO, is a useful tool. It may help you to determine whether your trial falls within the scope of the Clinical Trial Regulation (CTR). The tool also shows whether your trial is a low-intervention clinical trial. 

An overview of all European legislation for research with a medicinal product (including the ICH guidelines for Good Clinical Practice) is available in Eudralex Volume 10.