If you want to make changes to your approved research file that are non-substantial, you can do so via a non-substantial amendment.
What is the procedure?
Non-substantial amendments need not be submitted to us directly. They can be included in the next substantial amendment. Submission of this is done through the Research Portal.
What should I pay attention to?
Is my amendment non-substantial?
In principle, the sponsor / researcher determines whether an amendment is substantial or not. A guideline that can help you with this is that a substantial change has consequences for:
- the safety or integrity (both mentally and physically) of the participants
- the scientific value of the research
- the conduct and procedures of the investigation
- the quality or safety of any product used during the study