Notification of termination of the Clinical Investigation

The manufacturer, or his legal representative, is obliged to inform the FAMHP of the termination - premature or not - of a clinical investigation via

Subject of the notification: End of clinical investigation notification - 80M0XXX.

The manufacturer must attach a report signed by the Principal Investigator with a critical review of all data collected during the clinical investigation, including the identified adverse events.

The end date of the clinical investigation is the date of the last visit of the last patient to enter the investigation according to the established and approved protocol.

Notification of the end of a clinical investigation is not subject to a fee and is therefore free of charge.

Last updated on 28/11/2023