Modifications of the research file (amendments)
Modifications of the research file during the investigation should be reported to the review committee (accredited MREC or CCMO).
Amendments to the research file
The review committee (accredited METC or CCMO) usually takes note of minor amendments, such as textual corrections, for information purposes only. A further assessment by the review committee is required for substantial amendments, such as:
- a new participating centre;
- amendments that may have consequences for the safety of the study subject;
- amendments concerning the medical device.
How to submit an amendment
In the case of an amendment you are required to submit the following documents to the review committee:
- A signed cover letter (A1) with a description of the amendment(s) and an overview of all documents you are submitting;
- The amended and/or new documents listed in the MDR Annex XV chapter 2, possibly supplemented with a summary of the amendments per document (especially for protocol, IB medical devices and IMDD);
- A track-changes version of the modified documents;
- If the content of information in the ABR form (B1) changes, you also need to make and submit a new version of the ABR form. It is not required to modify the blocked questions at C17a for studies with a positive decision before May 26, 2021;
- A new version of the Eudamed form (B1a) for correct registration in Eudamed.
It is up to the review committee to determine whether a further assessment is required.
You do not need to report modifications to CCMO as competent authority.