Research Roadmap

During the study, new information may become available, or changes may be made to previously approved study documents (e.g. the study protocol or the subject information letter). Any new documents or modifications must be reported and, if deemed substantial, reviewed again by the review committee (MREC or CCMO).

Substantial amendments

A modifications is considered substantial if it affects:

• The safety, or the physical or mental integrity of participants;
• The scientific value, design, or management of the study;
• The quality or safety of the investigational medicinal product or other research products.

Examples of a substantial amendment include:

• A new participating centre;
• Additional study procedures, such as an additional blood sample;
• Change of principal investigator or independent expert;
• New version of the Investigator's Brochure (IB) or Investigational Medicinal Product/Device Dossier (IMPD/IMDD);
• Changes to the in- or exclusion criteria.

Non-substantial amendments

Non-substantial amendments do not require review or approval. However, the review committee takes note of minor modifications for information purposes.

Examples of non-substantial amendments include:

• Textual corrections;
• Modifications that do not affect the study's design or implementation.

Submission to review committee(s)

The CCMO website provides comprehensive information on amendments for each study type: medicinal products, medical devices, IVDs and other studies subject to the WMO.

Amendments for clinical trials involving medicinal products require submission via CTIS. For further details, refer to the CMC website.  

For other research subject to the WMO, MDR or IVDR, amendments must be submitted to the review committee via the Research Portal. Consult the MREC website for local procedures and the CCMO website for guidance on using the Research Portal.

Neither substantial nor non-substantial amendments need to be submitted to the CCMO as the competent authority.