Summary clinical trial results

Information on how to report the results of clinical investigations with medical devices can be found at Results clinical investigations.

You are required to submit a summary of the clinical trial results to the review committee (MREC or CCMO) within one year of the end of the trial (worldwide). You may submit a scientific publication or a summary of the clinical study report. Please upload a pdf in the web portal ToetsingOnline. If the file in ToetsingOnline has already been archived, please send an email to support@toetsingonline.nl with the request to remove the file from the archive, after which you can upload the results. The results of the study will be published in the CCMO register 15 days after they have been uploaded, unless the sponsor has objected with arguments.

In case of research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation) you are also required to submit a summary of the clinical trial results to the competent authority within one year of the end of the study (worldwide).

A template for a summary of a clinical trial report for research with a medicinal product can be found in annex 1 of the ICH E3 Guideline on the contents and structure of clinical study reports (CPMP/137/95).

The CCMO statement publication policy gives the viewpoint of the CCMO on how they think the publication of clinical trial results should be carried out.

Research with a medicinal product subject to the Dutch WMO Act (under previous legislation): clinical trial results in EudraCT and the EU Clinical Trial Register

For clinical research with medicinal products which falls under Directive 2001/20/EC the sponsor needs to add the study results to EudraCT. This initiative is based on the European Commission Guideline concerning posting and publication of result-related information on clinical trials, the European Commission Guideline 2012/C 302/03. The results for most trials must be reported within 12 months after the end of the study.

The study results will be published in the public EU Clinical Trials Register 15 days after a valid report in EudraCT, with the exception of most phase I trials. If the sponsor has not reported the results timely in EudraCT the study will be highlighted, which will be visible in the EU Clinical Trials Register.

Sponsors need to register on the EudraCT website to be able to add the study results to EudraCT.

More information can be found at the website of EMA.