End-of-study in accordance with the study protocol
Has your IVD performance study ended as defined in the study protocol? If so, please report the end date of the study to the review committee (accredited MREC or CCMO).
In the event of an end-of-study as defined in the study protocol, the sponsor must notify via the Research Portal the review committee concerned (accredited MREC or CCMO) as well as the CCMO as competent authority.
This deadline applies both to the end date of the study in the Netherlands and to the end date of the study in all EU Member States as well as worldwide.
A sample form is available indicating which questions should be answered.
Please note: This form is only a sample template of the questionnaire to be filled in online. It can not be completed or submitted as such.