Clinical Research

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

These two last documents do not have to be submitted before agreement negotiations start.

The agreement, once signed, 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.

Document Templates

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:

  • Agreement extension. 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:

Management expenses

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.

Contact

To use our services in connection with drugs and healthcare material clinical trials and EPA studies management, please contact:

Ms Laura Consuelo Arnal
Clinical trials management assistant
contratos_ec(ELIMINAR)@iislafe.es
(+34) 96 124 66 12 - Ext. 412608
Address: Avenida Fernando Abril Martorell, nº 106. Torre A, planta 7ª
Hospital Universitario y Politécnico La Fe
Secretaría del CEIm
46026 Valencia (Spain)

FAQ

When can I start filling up the agreement template?
Once you've got sufficient information to be able to complete all the prescribed fields.

You can download the agreement template any time.

We recommend consulting the trial/study with a CEIm at an earliest stage.

What local documents do I need to present to start the process?
Documents to be provided by the sponsor.

What is the agreement management fee?
The fees are available here.

How long before the planned commencement of the trial should I start the preparations?
The agreement preparation can run paralelly with your CEIm application so that there is sufficient time to deal with the financial and legal aspects as well as with internal documentation of the research site, the researcher and the collaboration team.

Can the contract be signed without having obtained the CEIm's approval?
Yes, a clarification as to the situation has to be annexed to the Agreement, however.

Who initiates the signing process?
Normally, the Institute would invite the parties to sign; there can be exceptions, however.

How many copies of the agreement are needed?
Standard is 3 copies (one for the Senior Researcher, one for the Institute and one for the sponsor); there can be exceptions, however.

In case of agreements that involve the Manises Hospital, four copies are needed (three copies as per above plus one for the Manises Hospital.

Where do I send the contracts? Who is the contact person?

Ms Laura Consuelo Arnal
Clinical trials management assistant
contratos_ec(ELIMINAR)@iislafe.es
(+34) 96 124 66 12 - Ext. 412608
Instituto de Investigación Sanitaria La Fe
Avenida Fernando Abril Martorell, nº 106- 46026 Valencia
Torre A, planta 7ª

Who reviews the Clinical Trials Agreements?
Clinical trials management assistant, currently Ms. Laura Consuelo Arnal, (contratos_ec(ELIMINAR)@iislafe.es) she also organizes the revision of the financial report by the Financial Department and the legal advisor of the Hospital.

Can English versions of agreements be signed?
The agreement cannot be only in English but it can be bilingual.

In case the sponsor uses this bilingual option, he will be responsible for making any changes made in the Spanish version be implemented in the English one.

How long does it take for everyone to sign?
That depends on the availability of the Institutes's and the Hospital's management, and of the researchers themselves. It normally takes app. 10 days, however.

Can a separate agreement be signed between the researcher and the sponsor?
No, in case of such a need, any mutual agreement between those two parties must form an annex of the overall agreement.

How is the financing plan of the agreement calculated?
From the established per patient cost, 25% are destined to cover indirect expenses and the rest goes to the chief researcher.

In case there are other collaborators, involved departments (pharmacy, nursery, etc.), corresponding expenses will be covered from the chief researcher's budget (up to 25% of his total).

When can the revision process of the financial part be commenced?
In case there are more parties involved (collaborating departments), the calculation can be done once they have agreed on the part they will play and have signed a collaboration agreement of involved departments (an internal Hospital document). 

What parts of the agreement get to be reviewed by the financial department?
Annex 2 of the financial report of the agreement, visits details, additional payments specified in the agreement as well as patient compensation (if applicable) and the form of payment specified by the sponsor.