Disclosure of study results

The CCMO discloses study results unless the sponsor of the study has made an objection. The disclosure of results applies to research files which have been submitted since 15 December 2015. The study results have to be submitted via ToetsingOnline. The report with the study results must consist of a lay summary and a scientific summary with study results. It is also possible to refer to a public website where the study results have been published.

The disclosure takes place in the CCMO register. The summary of the study results is disclosed in the CCMO register 15 days after it has been added to ToetsingOnline.

Objection procedure

The sponsor of the study can object to the CCMO with arguments against disclosure of the study results. You can send this objection by email to ccmo@ccmo.nl or by post to: CCMO, Postbus 16302, 2500 BH The Hague, the Netherlands. You should state in your email or letter that the objection is against the disclosure of the study results and also state the relevant file number (NL number in ToetsingOnline). Make sure that you submit the objection to the CCMO as a separate document. Do not, for example, submit it as an annex to a research file for the CCMO as the reviewing committee or competent authority. The CCMO will not process objections which are submitted as an annex to a file.

Your objection will be registered in the corresponding file in ToetsingOnline within seven calendar days after the objection has been upheld.