A.2.2) MATERIAL MODIFICATIONS
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.