In the event of the trial proving to be significantly more unfavourable to the subject than the research protocol had suggested, the investigator is required to suspend the study until such time as continuation is approved by the committee in question (MREC or CCMO). The reviewing committee must be notified of the decision to suspend the study immediately, giving reasons
Supsension research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation)
In case of suspension of research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation), you must also inform the competent authority by using the B5 Substantial Amendment Notification Form.
The suspension of the study must be reported immediately, stating the reason, if it concerns the safety of the subject. In all other cases, a notification period of up to 15 days applies.
Suspension research with medical devices
Information on how to report suspension of research with medical devices can be found at Temporary halt.