Temporary halt or (premature) end-of-study

Circumstances may lead to the temporary halt or early termination of a clinical investigation with a medical device. You are required to notify the review committee (accredited METC or CCMO) of any temporary halt or early termination of a clinical investigation with a medical device. In some cases you are also required to inform CCMO because of its role as the competent authority for clinical investigations with medical devices.

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