Starting date
You are required to inform the review committee (accredited MREC or CCMO) about the definite starting date of the IVD performance study by submitting a Status Progress in the Research Portal.
In general, the starting date of the study in the participating country is the date on which the first research participant signs the informed consent form. However, you may include a different date in your study protocol.
The start of a performance study has to take place within two years of the date of approval of your study. Is this period expiring? Then, before the term expires, submit an Other notification - Request to postpone decision via the Research Portal.