Disclosure of core data

The core data to be disclosed in OMON and ICTRP are included in the registry form. Not all data are being disclosed. Only the data marked as such (with a globe) will be published via onderzoekmetmensen.nl. The data is entered into the public CCMO register no more than seven working days after the decision by the reviewing committee, either positive of negative, has been registered. Following a positive decision also the globe marked data from the Status Progress will be published.

Objection procedure

The sponsor may object to the disclosure of the core data in OMON and ICTRP by submitting an Other notification in the Research Portal. The objection must contain arguments as to why the core data of a specific study should be barred from publication in OMON and ICTRP. The CCMO assesses these requests on an individual (study) basis and may ask the sponsor to submit the relevant information. Requests may be submitted in the Research Portal for all types of clinical research.

If the objection is granted there will be a registration of non-disclosure in the relevant file within seven calendar days.