Data updated as of January 2025

Clinical Trials without drugs or healthcare products, Research Projects with or without biological samples, observational studies without drugs, according to the applicable legislation and regulated by Law 14/2007 on Biomedical Research This link opens in a popup window.

The following documentation shall be submitted to CEIm-FJD Secretary in electronic format (ceic@fjd.esThis link opens in a popup window):

4.1. Initial evaluation request

  • Letter or email addressed to CEIm requesting the evaluation of the study
  • Study protocol, preferably in Spanish (template available in the files below)
  • Data Collection Book (CRF)
  • Patient Information Sheet and Informed Consent form. The following models can be used in the available files
  • Researcher and Collaborator Commitment signed, according to the following modelThis link opens in a popup window. The main researcher must be a physician from the center where it is conducted, and the students/resident, if any, become collaborators.
  • Proposed financial report or financial compensation for the researchers and the center, if any
  • For retrospective studies, a signed Researcher and Collaborator Commitment, undertaking not to re-identify patient data (download below, in the available files)
  • Request for Invoice of Fees This link opens in a popup windowfor protocol evaluation:
    • €1,000 plus VAT for research projects with or without biological samples and observational studies without drugs
    • €1,000 plus VAT for Clinical Trials without drugs or healthcare products
    • The invoice request must specify the data of the study and the fiscal data for invoicing and shipping (in the case of private entities). 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.
    • If a contract is to be formalised, a management fee of €500 plus VAT for Project and Study contracts and €3000 plus VAT for Clinical Trial contracts will be charged upon signing. To download the models, go to ‘Contract management’ This link opens in a popup window.

4.2. Request for evaluation of a relevant amendment

  • 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.
  • For center expansions, the applicable local documents must be provided (CV, LR Commitment, insurance policy, etc.)
  • 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