3. OBSERVATIONAL STUDIES WITH/WITHOUT DRUGS

Data updated as of January 2025

The sponsor (or the representative CRO) shall send to the following documentation to the CEIm FJD Secretarial Office via email (ceic@fjd.es):

3.1. Request for initial evaluation:

Pursuant to the provisions of Royal Decree 957/2020 of 3 November, on regulating observational studies with drugs for human use:

• Complete protocol, adapted as far as possible to the structure and content detailed in Annex I of the Royal Decree. It may be accepted in English, with a summary in the official language of the State. The version and date shall be indicated.
• Participating patient information sheet and informed consent form, or justification for waiver. The version and date shall be indicated.
• List of researchers from each of the healthcare centers in which the study is proposed to be carried out, and the number of participating subjects to be included in each autonomous community. If the study is planned to be carried out in other countries, list of countries.
• Sources of funding for the study and compensation planned for participating subjects and researchers, if applicable. In the case of non-commercial clinical research, the sponsor must submit a liability declaration signed by the sponsor and by the coordinating researcher that the study complies with all the conditions referred to in paragraph e) of Article 2.2 of Royal Decree 1090/2015, of 4 December.
• Data collection form.
• If the application is not submitted by the sponsor, it must include a document indicating the tasks delegated by the sponsor to the person or company acting on their behalf.
• If applicable, documentation of the approval of the protocol by the corresponding body, in the case of a study imposed on the commercial authorisation holder of a drug by the national competent authority or the European Commission.
• In addition, you must provide:

1. Main researcher and collaborator commitment, completed and signed.
2. Liability Declaration, if applicable, as established by Royal Decree 957/2020, of 3 November, regulating observational studies with drugs for human use, that the study complies with all the conditions of art. 2.2., e), of RD 1090/2015.
3. Request for Invoice of Fees for protocol evaluation: €1,000 plus the corresponding VAT, in which you will have to specify the data of the study and the fiscal data for invoicing and shipping (send an e-mail requesting an invoice).
4. If a contract is formalised with the sponsor, a Management Fee of €1,000 + VAT will be charged upon signing the contract. To download the models, go to ‘Contract management ’.
5. Delegation of responsibilities from the Sponsor to the CRO, if applicable, authenticated before a Notary Public (or Apostille of The Hague) for signing the contract and/or invoicing.

3.2. Request for evaluation of Relevant Amendments:

• Letter of request for amendment evaluation
• Summary of changes, proposed modification and justification thereof.
• Documents showing all changes made, highlighted with change control and cleaned up.
• Request for Invoice of Fees for protocol evaluation: €500 plus the corresponding VAT, in which you will have to specify the data of the study and the fiscal data for invoicing and shipping (send an e-mail requesting an invoice). For exemption from payment of study evaluation fees, each case will be evaluated on an individual basis, especially considering cases in which there is no payment for researchers. The sponsor/researcher must provide a written justification for the exemption.

3.3. Observational studies with a favourable opinion from an accredited CEI in Spain

The favourable opinion of any accredited CEIm in our country will be recognized by the CEIm-FJD, thus not requiring additional evaluations of ethical aspects. However, the studies are subject to rapid evaluation by a CEIm-FJD Subcommittee, except for EOm, which are not evaluated, but are registered, and whose opinion is unique, binding and recognised nationwide.

The documentation required for fast assessment or registration in the case of EOm, and which may be provided by the sponsor/researcher at any time, in electronic format (ceic@fjd.es), to formalise the Conformity of the Center Management and the contract with the Fundación Jiménez Díaz Health Research Institute Foundation will be:

1. • Request for study evaluation via email.
   • Protocol for filing with the Secretarial Office, including the Patient Information and Informed Consent Form, adapted to the center where the procedure is performed. The HIP-CI model can be used.
   • Approval report from the CEI that has evaluated the study, indicating the centers where the study was carried out or, failing this, a list of centers.
   • Main researcher and collaborator commitment, completed and signed.
   • Liability Declaration, if applicable, as established by Royal Decree 957/2020, of 3 November, regulating observational studies with drugs for human use, that the study complies with all the conditions of art. 2.2., e), of RD 1090/2015.
   • Financial report (number of patients to be included, payment per patient, payment to the Hospital, etc.),
   • If a contract is formalised with the sponsor, a Management Fee of €1,000 + VAT will be charged upon its signing. To download the models, go to ‘Contract management ’.
   • Delegation of responsibilities from the Sponsor to the CRO, if applicable, authenticated before a Notary Public (or Apostille of The Hague) for signing the contract and invoicing.
   • Request for Invoice of Fees for protocol evaluation: €200 plus the corresponding VAT, in which you will have to specify the data of the study and the fiscal data for invoicing and shipping (send an e-mail requesting an invoice). For exemption from payment of study evaluation fees, each case will be evaluated on an individual basis, especially considering cases in which there is no payment for researchers. The sponsor/researcher must provide a written justification for the exemption.