A modification is substantial if it is likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study.
Submit a notification for a substantial modification
The following documentation shall be submitted to NoMA by e-mail to firstname.lastname@example.org:
- Notification form (‘Substantial modification of a performance study’)
- Documents that are changed due to the planned modification. Changes shall be clearly identifiable.
- If the modification involves new principal investigators or investigation sites, the following must be submitted
- CV for the principal investigator
- Confirmation on the suitability of the investigational site(s). The confirmation should be signed by the person in charge at the investigational site.
A separate notification must be sent to the Regional Committees for Medical and Health Research Ethics (REC). Please contact REC for details on submission.
Implementation of a substantial modification
The sponsor may implement the modification at the earliest 38 days after NoMA and REC have been notified, unless NoMA notifies the sponsor of a refusal or a negative opinion has been issued by REC.
The time period may be extended by a further seven days, if NoMA or REC need to consult external experts for the assessment of the notification. In that case, the sponsor will be informed about the extended time period.