The following shall be forwarded to the Secretariat of the FJD Clinical Research Ethics Committee, Avda. Reyes Católicos, 2, 5ª planta in CD format:

  • Submission letter accompanying the request for a ruling and 1 hard copy with proof of receipt; this shall include the name, address, telephone and fax numbers, and e-mail address of the person in charge of oversight or the contact person for the clinical trial.
  • Request form (Appendix A).
  • Protocol for the clinical trial (preferably in Spanish) signed by the investigator and the sponsor (protocol agreement, signature page). For protocols drafted in English, a summary of the protocol must be included.
  • Researcher's Manual.
  • Case Report Forms.
  • Protocol summary.
  • Patient information document and informed consent for study subjects.
  • Certificate and/or specific insurance policy for the study site.
  • Documents on the qualifications of the investigator and his or her collaborators.
  • Documents on the appropriateness of the facilities.
  • Procedures and materials used to recruit subjects, where applicable.
  • Compensation proposal for subjects, the study site, and researchers, where applicable.
  • Abridged CVs (maximum two pages) of the principal investigator and collaborators. Commitment of the investigator and collaborators.
  • Authorization from the services involved.
  • Request for invoice— processing fee €900 + VAT* (please specify the trial information, tax ID information, and mailing address).
  • Assignation of responsible parties (signing and billing) for the sponsor and, where applicable, the CRI; these must be notarized.

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

Note: The sponsor must insure that all ethics committees involved have properly received all documents within the aforementioned period and shall inform the reference committee to the effect via the following e-mail address: This link opens in a popup window.