Substantial Amendments

You want to change your (previously approved) research file via a substantial amendment. The MREC needs to approve this. 

What is the procedure?

You should submit the substantial amendment digitally. 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 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

You must also submit a signed B5 form (EudraCT notification of amendment form). This only applies to drug research. You should also send us the new and / or amended documents. Please number and name your documents according to the CCMO standard research file.

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. 

Please send us the signed cover letter by post. You can send us the amendment: 

  • digitally via your own portal or medium of your choice
  • by email in attachment(s): info@stbebo.nl 
  • on USB by post 

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: 

  1. the safety or integrity (both mentally and physically) of the participants
  2. the scientific value of the research
  3. the conduct and procedures of the investigation
  4. 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. The latter also applies to CVs of principal investigators and independent physicians. 

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. You must also send us this cover letter by post. 

MREC Assen