Early termination
Has your IVD performance study ended earlier than foreseen in the protocol? If so, you are required to report this via the Research Portal.
In the event of an early termination for safety reasons, the sponsor must notify within 24 hours all EU Member States in which the study is carried out.
In the event of an early termination of studies in the Netherlands for reasons other than safety, the sponsor must report this within 15 calendar days in the Research Portal.
The submission via the Research Portal suffices for both the review committee and the competent authority for performance studies with IVDs.
A sample form is available that shows which questions are to be answered.
Please note: this form is only an example of the questionnaire you must complete. It cannot be filled in or submitted as such.