You want to change your (previously approved) research file via a substantial amendment. The MREC needs to approve this.
What is the procedure?
You submit the substantive amendment digitally through the Research Portal. We aim to review your amendment within 10 working days. For reference: the legal timeline allows for 35 days. However, some amendments have a very significant impact. Our chairman may decide that such an amendment should be discussed in a MREC meeting. This happens almost exclusively when the design of the study changes. In such a case, the review process may take longer. We will inform you about this. In that case we are still bound by the legal timeline. Upon approval of a substantial amendment, you will receive a Letter of Approval within 10 working days.
What should I submit?
You should submit the substantial amendment through the Research Portal along with a cover letter. In the cover letter, you should provide a summary of the change(s) and the reason(s) for it. This rationale allows for a quick review.
If previously approved documents have changed, you must send us Track Changes versions. These are indispensable for the review process, and allow for a quick review.
What should I pay attention to?
Is my amendment 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
What requirements should the submitted documents meet?
In general, submitted documents should have a version number and / or be dated. Always ensure that submitted forms (see Part B of the CCMO standard research file) are dated and signed.
What if there is a resubmission?
When you submit a substantial amendment we might request that the submitted documents be amended. When you submit the resubmission, a cover letter must be included.