Amendments

When, after the initiation of a clinical investigation, the sponsor wishes to make substantial changes to the protocol or any other document that may affect the safety of the participants, or lead to a different interpretation of the scientific documents that govern the conduct of the investigation or if these changes are significant from another point of view, the investigator shall report the reasons and content of these changes to the appropriate ethics committee (s) by means of an amendment.


Amendments must be submitted and approved by the ethics committee. Amendments are not subject to approval by the FAMHP and can therefore be implemented as soon as the ethics committee has given its approval.


However, the FAMHP wishes to be informed by e-mail of the changes made to the studies it has approved.


That is why the FAMHP asks the manufacturer, or his legal representative, to forward this information electronically to the Research and Development (human use) department of the FAMHP. This can be done via the email address ct.rd@fagg.be or via the Common European Submission Platform (CESP). The following elements must be provided:

  • cover letter - Subject: Amendment of clinical investigation - 80M0XXX, specifying the title of the study and a summary of the changes made,
  • the amended documents,
  • a copy of the favorable opinion of the ethics committee, including the versions of the documents to which this approval relates.

Notification of amendments is not subject to a fee and is therefore free of charge.

 

Last updated on 13/04/2021