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 the Research Portal. 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 results are published in OMON and ICTRP 15 days after they have been submitted in the Research Portal. 

Objection procedure

The sponsor of the study may object to the CCMO with arguments against disclosure of the study results in OMON and ICTRP by submitting an Other notification in the Research Portal. After the objection has been granted it will be registered in the corresponding file within seven calendar days, stating that no study results will be published in OMON and ICTRP.