In order to begin the process of feasibility and start-up of the trial, the following essential documentation is required:


  • Documents called ‘Initial application form-EMA’ (Part 1, Part 2) that is generated when the Trial documentation is submitted to CTIS. In the case of Research with Healthcare Products (ICPS) this point is not necessary.
  • Protocol in English or Spanish and a summary of the protocol in Spanish, to communicate the objectives, design, methodology and organisation of the trial.
  • Indicate the evaluating CEIm and, if authorised, provide CEIm approval report and AEM authorisation.
  • Certificate of insuranceThis link opens in a popup window stating the correct name of the center and complying with the requirements of the RD
  • Facility SuitabilityThis link opens in a popup window submitted to the CEIm that has evaluated/approved the trial including the estimated number of patients.
  • Conformity of the Area(s) involvedThis link opens in a popup window completed and signed by the head of the corresponding Area. The research team should provide these documents to the sponsor for submission to the CEImFJD.
  • The detailed financial report (Excel document), specifying the procedures included per visit, tests and the complementary procedures, with their respective costs.
  • Compensacion prestacion servicio (134.7 KB )
  • Letter of delegation from the sponsor to the company acting as CRO, notarised, or with the Apostille of The Hague when executed before a non-Spanish notary, in applicable cases.
  • In the event that changes are made to the initial contract, an Addendum to the contract will be signed, for which 500 euros will be charged as an Addendum management fee (addendum models). In the event that the Addendum is for changes in the budget, 1,000 euros will be charged.
  • Contract management and other costs

Clinical Trial Contract Models Our Contract models CHANGES ARE NOT ALLOWED