Disclosure of core data
The core data which is disclosed in the CCMO register, is included in the ABR form. Not all data from the ABR form is disclosed via the register. Only the data which is marked as such (with a globe) can be viewed publicly via the register. The data is entered into the public CCMO register no more than seven working days after the positive or negative decision by the reviewing committee (accredited MREC or CCMO) has been included in the ToetsingOnline web portal by the MREC/CCMO. The disclosure in the CCMO register of core data from phase I studies with healthy volunteers only takes place six months after the decision by the reviewing MREC has been registered in ToetsingOnline.
The sponsor of the study can object to the CCMO against the disclosure of the core data in the CCMO register. The objection must contain arguments as to why the core data of a specific study has to be kept out of the CCMO register. The CCMO assesses these requests on an individual (study) basis and can ask the sponsor to submit the relevant research protocol. Requests can be submitted for all types of clinical research.
You can send the objection by email to firstname.lastname@example.org 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 core data from the ABR form and also state the relevant file number (NL number). 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.