Clinical trial agreements where one of the parties is the La Fe Hospital or the Manises Hospital are subject to conditions described below.
The Research Foundation of the La Fe Hosppital also manages agreements for trials conducted in the Manises Hospital, in line with the Frame Agreement on Collaboration ('Acuerdo Marco de Colaboración'), from February 27, 2012, where it is stipulated that the biomedical research (and the trial agreements) conucted in the Manises Hospital is under the management of the IIS-Fundación La Fe.
Documents to be provided by the sponsor
In case the La Fe's CEIm is not the evaluating authority of the clinical trial, the sponsor shall deliver the following documents before signing the agreement:
- Protocol signed by the Senior Researcher
- Financial Report
- Standard Insurance Certificate
- Authorization Application Form (Annex 1A)
In adition, the sponsor shall present the following documents when ready:
- CEIm's approval
- Patient information sheet
The latter two documents do not condition the start of contract management.
Once the parties have formalised the contract, the agreement takes effect when the trial in question is authorized by the Spanish Agency of Medicines and Healtcare products (Agencia Española de Medicamentos y Productos Sanitarios) and is also approved by the corresponding Ethical Committee.
The following contract template (in its different language versions) is currently in use in the Valencian Community, based on the Council's (Consell) Decree no. 73/2009 of June 5 on clinical trials regulation:
Clinical Trials Agreement Template
EPA Study Contract
This approach is appropriate if a delay (or a foreclosure) occurs for reasons you cannot anticipate or control, the reasons have been adequately addressed, and the clinical trial remains a high priority. Also, if there are relevant changes that imply a change in the cost of the trial, an agreement amendement and/or extension is in order. Templates below:
The fee for the management of a clinical trial, EPA study, health proucts clinical studies as well as for the management of agreement amendments is: 500€ (excl. VAT).
This fee is due upon the signing of the agreement or its amendment and its payment does not depend on a favourable decision of the CEIm or AEMPS.
PTo use our services in connection with drugs and healthcare material clinical trials and EPA studies management, please contact: contratos_ec(ELIMINAR)@iislafe.es.