The following shall be forwarded to the Technical Secretariat of the FJD in CD format:

  • Request for evaluation of modification and 1 hard copy with proof of receipt.
  • Summary of the trial protocol.
  • Summary of the changes, proposed modification, and justification of the modification.
  • In case of changes affecting the informed consent document, a revised patient information document and informed consent document. All changes made should be appropriately marked (e.g., italics, underlined).
  • Request for invoice—processing fee €300 + VAT* (please specify the trial information, tax ID information, and mailing address).

* Requests for exemption from payment of the processing fee will be evaluated on a case-by-case basis.