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?
You should submit the non-substantial amendment digitally. We aim to process your amendment within 10 working days. Our MREC checks if the submission and the documents are in order. Subsequently, the submitted documents will be added to the research file. We will not send you a confirmation of receipt, unless you ask us to do so. The MREC does not issue a Letter of Approval and / or other approval for non-substantial amendments.
In principle, the MREC will not review the contents of the non-substantial amendment.
What should I submit?
You must submit the non-substantial amendment with a cover letter. In it, please state the reason(s) for the amendment. This rationale is important for us to quickly process your documents.
Please enclose the documents to be added and / or amended. If previously approved documents have been changed, we would also like to receive the track changes versions.
In general, submitted documents should have a version number and / or must be dated.
You can send us the amendment:
- digitally via your own portal or medium of your choice
- by email in attachment(s): info@stbebo.nl
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