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Summary clinical trial results

Information on reporting the results of clinical investigations with medical devices is available at Results clinical investigations.

You are required to submit a summary of the clinical trial results via the Research Portal within one year of the end of the trial (worldwide). You are required to complete the Study Result form. In addition you can submit a scientific publication and a (lay) summary of the study report in the document's section.

The results of the study will be published in the Overview of Medical Research in the Netherlands (OMON) 15 days after they have been uploaded, unless the sponsor has objected with arguments.

The CCMO statement publication policy  states CCMO's view of publishing clinical trial results. 

Research with a medicinal product subject to the Dutch WMO Act (under previous legislation), not having been migrated to CTR

Submitting the results through the Research Portal is sufficient. Separately submitting the results to the competent authorities is no longer required.

Clinical trial results in EudraCT and the EU Clinical Trial Register

For clinical research with medicinal products falling under Directive 2001/20/EC that has not been transferred to the EU-Cinical Trial Regulation 536/2014 the sponsor is required 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 EMA website.