Substantial modifications to a performance study
If a sponsor intends to introduce substantial modifications to a performance study, NoMA must be notified in advance.
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 email@example.com:
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 (REK). Please contact REK for details on submission.
Implementation of a substantial modification
The sponsor may implement the modification at the earliest 38 days after NoMA and REK have been notified, unless NoMA notifies the sponsor of a refusal or a negative opinion has been issued by REK.
The time period may be extended by an additional seven days if there is a need to consult experts in the assessment of the notification. In that case, the sponsor will be informed about the extended time period.