A.1.1) CLINICAL TRIAL USING MEDICINES OR MEDICAL DEVICES
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: firstname.lastname@example.org .