Temporary halt or (premature) end-of-study

Circumstances may lead to the temporary halt or early termination of an IVD performance study. You are required to notify the review committee (accredited MREC or CCMO) of any temporary halt or early termination of an IVD performance study. In some cases you are also required to inform CCMO because of its role as the competent authority.

Information on how to report the temporary halt, early termination or end-of-study in accordance with the study protocol can be found on the following pages: