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Changes to the research file (amendments)

Minor changes, such as textual changes, are generally only noted by the reviewing committee (MREC or CCMO).

Substantial amendments

Substantial amendments must undergo further review. Substantial amendments are changes to any aspect of the study that may substantially affect the safety or rights of the research participant, or the reliability and robustness of the generated data. 

A few examples of substantial amendments are:

  • a new participating center,
  • a new research procedure for the primary endpoint,
  • a change in study design,
  • new version of the participants information sheet,
  • a new research participant's insurance.

Cover letter

For an amendment, you are required to submit a signed cover letter, and all amended and/or new documents clearly stating the changes. You may do so in the cover letter or in a summary of changes for each document. Please submit both a clean version and a track changes version for each document. If the information in the ABR form changes because of the amendment, you are required to amend the ABR form as well. 

Summarizing, in the case of an amendment you have to submit the following documents to the reviewing committee (MREC or CCMO):

  • Cover letter (A1) containing a description of the modification(s) and an oversight of all the documents you are submitting.
  • The modified and/or new documents, if applicable supplemented with a summary of changes for each document (in particular for protocol and subject information sheet).
  • A track changes version of the modified document.
  • If the content of the information in the ABR-form (B1a) changes, you are required to amend the ABR-form and submit it as well.
  • If the change concerns the subject information sheet, and subjects have already been included in the study, a summary of the changes can be of value to the subjects. If such an addendum is used, this document must be submitted to the reviewing committee as well.

For the way of submitting, see How to submit to the review committee.

The review committee decides if a further decision is necessary. Ask the accredited MREC in question or the CCMO about their policy. A further decision is subject to the so-called ‘reasonable timeline’ of 8 weeks as stated in the General Administrative Act Law (Algemene wet bestuursrecht, Awb). This timeline can be extended with a maximum of 8 weeks.

The Penalty and Appeal Act (Wet Dwangsom en beroep bij niet tijdig beslissen) applies when a request for a further decision is not reviewed within the legal timeline by an accredited MREC or the CCMO. If you do not agree with a decision made by an MREC then you can, as an interested party and under certain conditions, submit an administrative appeal to the CCMO. If you do not agree with a decision made by the CCMO then you can submit an objection to the CCMO.

Clinical investigations with medical devices

Information on how to submit adjustments of the research file for clinical investigations with medical devices can be found at Adjustments of the research file (amendments).

Addition of a participating centre

Addition of a new participating centre is considered a substantial amendment and must be submitted for review to the reviewing committee (MREC or CCMO).