Research with a medicinal product

From 31 January 2023, any new scientific research with a medicinal product must comply with the Clinical Trial Regulation and be submitted in CTIS. More information on research with a medicinal product can be found at Clinical trials with medicinal products (CTR).

Ongoing research with a medicinal product subject to the WMO (Medical Research Involving Human Subjects Act)  (under outdated legislation) should be completed before 31 January 2025 or else transferred to CTIS. Until then, amendments and other relevant information for ongoing research can still be submitted outside CTIS (During and after the research | Investigators | The Central Committee on Research Involving Human Subjects (ccmo.nl)

A clear definition of the term research with a medicinal product is not always easy to make. The Clinical Trial Decision Tool, developed jointly by Paul Janssen Futurelab and CCMO, is a useful tool. It can 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.