Do you want to start a clinical trial?
At what point can the contract be started?
Once sufficient information is available to complete the model contract. The model can be downloaded at any time. It is recommended that the study be submitted to an CEIm in order to start the negotiation.
What local documentation must be provided at the start of the procedure?
Documentation to be provided by the promoter.
What is the contract management fee?
The management fees are available at this link.
How far in advance is it advisable to start the process?
The contractual process can be initiated in parallel to its submission to CEIm, so that time is available to manage the legal and financial aspects, as well as the internal documents of the centre with the collaborating researcher and team.
Can the signature process be initiated without CEIm approval?
Si, incluyendo una aclaración en el Anexo I del contrato.
Who initiates the signature process?
Usually the IIS La Fe, unless an exception is decided.
How many copies are needed?
Generally 3 (one copy for the principal investigator, one for the IIS La Fe and one for the promoter), unless an exception is decided. In the case of contracts managed with the Hospital de Manises (Valencia), 4 copies are required (one for the principal investigator, one for the management of the Hospital de Manises, one for the promoter and one for the IIS La Fe.
To what address do contracts have to be sent?
Can contracts be signed in English?
No. The contract can be bilingual. In the event that the promoter chooses this model, he must adapt the changes made in the Spanish part to the English part.
How long does it take to complete the signature circuit?
Depende de la disponibilidad y agendas de Dirección del IIS La Fe, Gerencia del Hospital U. y P. La Fe y de los propios investigadores. No obstante, el tiempo aproximado suele ser de una semana y media.
Can a separate agreement be signed between the promoter and the researcher?
No. If they wish to do so, they must attach it to the trial contract.
How is the economic memory of the contract calculated?
From the established cost per patient, 25% is allocated to cover indirect costs and the remaining 75% to the principal investigator. In the case of collaboration with other services involved (pharmacy, nursing, etc.), the percentage for collaboration will be taken from the investigator's share (up to a maximum of 25% of the investigator's share may be allocated to the collaborating services).
When can the review of the economic part be initiated?
In the case of the participation of other collaborating services, once their percentage of collaboration has been agreed and they have signed the collaboration document of the services involved (internal document of the IIS Hospital La Fe).
Which parts does the economic department review in the contract?
Annex II of the financial report of the contract, details of visits, additional payments indicated in the contract, as well as compensation to patients (if applicable) and the form of payment established by the promoter.