A.1.3) MATERIAL MODIFICATIONS
Se presentará en la Secretaría del CEIC-FJD, Avda. Reyes Católicos, 2, 5ª planta, la siguiente documentación en
The following shall be forwarded to the Secretariat of the FJD Clinical Research Ethics Committee, Avda. Reyes Católicos, 2, 5ª planta 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.
Notes: Each ethics committee involved shall send the aforementioned documents in the formats indicated by each ethics committee (except the request for invoice for the processing fee).