B1a. ABR form
The ABR form is the General Assessment and Registration form. You are required to complete the ABR form online in the Research Portal.
It is possible to save the completed form in the Research Portal as a PDF. You will also receive a PDF of the form via email after the form has been submitted. The PDF should be archived in your research file.
A sample form is available that shows which questions must be filled in. Please note: this form is only a sample template of the questionnaire that you need to fill in online. It cannot be filled in or submitted as such.
Please note! In the case of IVD performance studies falling under article 58 or 70.2 of the IVDR, the study must be submitted to CCMO for validation. After a positive validation decision, CCMO forwards your file to the review committee (accredited MREC or CCMO) you have indicated as your preference in the Research Portal.
In all other cases your file is forwarded directly to the review committee of your preference.