B.2) STUDIES PREVIOUSLY APPROVED BY OTHER ACCREDITED ETHICS COMMITTEES
Favorable rulings handed down by any accredited ethics committee in our country regarding a post-authorization study or an epidemiological study not meeting the characteristics of a post authorization study shall be recognized by health authorities or publicly funded bodies, hospital management, and the hospital's ethics committee; no additional rulings will be required with regard to the ethical aspects of studies previously evaluated by other ethics committees.
The electronic documents that must be submitted for formal authorization of the Center management and the contract with the IIS-FJD is the following:
- Sponsor contact information: Monitor name, telephone number, and e-mail address.
- Protocol for archiving by the Secretariat; this must include the patient information sheet and informed consent document.
- Approval report from the ethics committee that has evaluated the study.
- Statement of commitment of the investigator and collaborators of the study site.
- 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. Financial report (e.g., number of patients, per-patient payments, payments made to the hospital) for the drafting of the contract with the center. A handling fee of €200 will be charged upon signing of the contract.
- Assignation of responsible parties (signing and billing) for the sponsor and, where applicable, the CRI; these must be notarized.
All documents must be presented in the specified format to the following address:
Technical Secretariat of the Clinical Research Ethics Committee
Institute of Biomedical Research-Fundación Jiménez Díaz
Avda. Reyes Católicos, 2, 5ª planta (Ascensores 4-5)
28040 – Madrid
Notes: All documents requiring proof of receipt on paper must include a self-addressed, stamped envelope so that the proper document may be sent. No other procedures will receive paper proof-of-receipt.