Clinical Research
Contract models
Contracts for clinical studies signed with the Hospital Universitari i Politècnic La Fe and the Hospital de Manises will be managed according to the instructions described below.
Under the framework agreement between the Generalitat, through the Conselleria de Sanidad Universal y Salud Pública and the Fundación para la Investigación del Hospital Universitario y Politécnico La Fe de la Comunitat Valenciana - Instituto de Investigación Sanitaria La Fe (IIS La Fe), dated 24 May 2022, IIS La Fe will manage the development of clinical studies in the department, establishing the contractual relationship with the sponsors of the studies and with the department. IIS La Fe will also manage the contracts for the studies carried out at the Hospital de Manises.
In order to accelerate the implementation of a Clinical Trial, Observational Study or Research Project, we offer the possibility of initiating the negotiation of the contract in parallel to obtaining the approvals.
Documents to be provided by the sponsor
in the event that CEIm La Fe has not been the evaluating committee for the clinical trial, the Sponsor must submit the following documentation at the time of initiating the processing and signing of the contract:
- Protocol
- Financial Report
- Model Insurance Certificate
- CEIm approval opinion (when available).
- This last document does not condition the start of contract management.
Once the parties have formalised the contract, it will be effective when the clinical trial is authorised by the Spanish Agency for Medicines and Health Products and has the favourable opinion of the corresponding Ethics Committee in each case.
Templates
Our centre works with the models approved by the IISLAFE Governing Bodies on 25 April 2023, which cannot be modified.
Clinical Trial Contract Models for Medicines or Medical Devices
Observational Drug Study Contract Models
Research Project Contract Models
Addendum to the contract. In the event of an extension of the Clinical Trial, Observational Study or Research Project, or a relevant modification that implies an increase or decrease in the cost of the clinical study initially planned, an addendum to the contract shall be made.
Management expenses
The fees established for the management of the above-mentioned clinical trial contracts, which were approved by the IISLAFE Governing Bodies on 25 April 2023, are as follows:
| Concepto | Cuota |
|---|---|
| Clinical Trial with Medicinal Product or Medical Device | 1.500,00 EUR |
| Observational Study with Medicinal Product (EOm) | 1.000,00 EUR |
|
Research Project (PI) |
1.000,00 EUR |
|
Contract Addendum (Clinical Trial, EOm & PI) |
500,00 EUR |
| Custody of the clinical trial investigator's file | 600,00 EUR |
The established fee for the custody of the investigator's file at the end of the clinical trial is €600 in a single payment, which will be paid together with the contract management fee.
These fees will be invoiced from the signing of the contract or addendum, without being conditional upon approval of the contract by the CEIm or the AEMPS.
Contact
To manage clinical trial contracts with medicinal products or medical devices, observational studies and research projects, please contact: contratos_ec(ELIMINAR)@iislafe.es.