B.1) STUDIES TO BE ASSESSED BY THE FJD ETHICS COMMITTEE
The following shall be forwarded to the Technical Secretariat of the FJD in CD format:
- Request for evaluation of the study and 1 hard copy with proof of receipt
- Study protocol, preferably in Spanish
- Case report forms, where applicable
- Product characteristics of the drugs being studied, where applicable
- Patient information document and informed consent for study subjects
- Signed copy of the statement of commitment of the principal investigator and collaborators
- To sign a contract with the study site, include a compensation proposal for subjects, the study site, and researchers (where applicable). A handling fee of €200 will be charged upon signing of the contract.
- Classification according to Spanish SAS 3740/2009 and based on the type of authorization:
-Post-authorization studies at the request of regulatory authorities: authorization of the SAMMD
-Post-authorization observational studies promoted by health authorities or publicly funded bodies: authorization of the SAMMD
-Post-authorization observational studies of prospective follow-up: authorization of region of Spain in question
-Post-authorization studies other than the design of prospective follow-up: no SAMMD authorization request if ethics committee authorization is required
-Epidemiological studies that do not meet the characteristics of a post-authorization study: no SAMMD authorization request if ethics committee authorization is required
- Request for invoice—processing fee for protocol appraisal €300 plus VAT; the information on the study and the tax ID and mailing address must be included.
- Requests for exemption from payment of the appraisal fee will be evaluated on a case-by-case basis; studies that do not call for any payment to the researchers will be given especially close attention.
- Assignation of responsible parties (signing and billing) for the sponsor and, where applicable, the CRI; these must be notarized.