Suspension of study
The sponsor is responsible for timely reporting a suspension of the study. The sponsor should always cite the reason for the suspension in the notification. The sponsor is required to report the suspension in the Research Portal.
Clinical investigations for conformity purposes (MDR article 62/74.2) or post-market clinical follow-up investigations (MDR article 74.1)
In the event of a suspension for safety reasons, the sponsor must notify within 24 hours all EU Member States in which the clinical investigation is carried out.
In the event of a suspension of clinical investigations in the Netherlands for reasons other than safety, the sponsor must report this within 15 calendar days.
Clinical investigations that have been suspended for safety reasons may only be restarted upon approval by the review committee. The restart permission is requested by submitting an amendment in the Research Portal. The sponsor must report the restart of the clinical investigation via a Status Progress in the Research Portal.
Other clinical investigations (MDR article 82) or studies with a positive decision prior to 26 May 2021 (WMO article 10, subsections 4 and 5a)
The sponsor is required to report the suspension immediately (within 24 hours) in the Research Portal. Clinical investigations that have been suspended for safety reasons may only be restarted upon approval by the review committee.