Clinical Trials

In this section, we offer you all the necessary information to carry out clinical studies, research with medical devices or observational studies in the Health Area of Salamanca, including the Complejo Asistencial Universitario de Salamanca (CAUSA) and the Primary Care Health Centers.

Are you a sponsor or a CRO and want to conduct a clinical trial?

Here you will find guides on how to obtain a facility suitability document, negotiate and sign performance contracts, and access online forms that facilitate the process and ensure efficient processing of your applications.

We remind you that, before the start of the clinical study, a contract must be signed between the sponsor or CRO, Management, the principal investigator and the IBSAL, establishing the obligations and responsibilities of each party, as well as the economic aspects.

UICEC
CEIm
FAQs

Obtaining suitability

Contract management

Model for clinical trials

Models for research with sanitary products

Models for observational studies with medication

Models for research projects and other observational studies

Facility Suitability Application Form

EECC/ICPS/EEOO Contract Negotiation Initiation Form

Form to process invoice requests for EECC/ICPS/EEOO contract

Frequently Asked Questions

Can the clinical trial contract be signed before obtaining the CEIM opinion and the AEMPS authorization?

Yes, but only in the case of clinical trials and clinical research with medical devices. In the model contract there is a suspensive clause that allows this. When the Sponsor/CRO has these documents it should send them to ensayosclinicos@ibsal.es.

No

Yes

Yes, it is included in the model contract and addendum. Exemption from payment can be requested. In the case of clinical trials, it is also necessary to have paid the facility suitability procedure (April 2024).

Only our bilingual Spanish-English model is accepted, in case of discrepancies between texts, only the Spanish version is valid. Only the Spanish version is reviewed and the promoter/CRO has to adapt the changes from the Spanish text to the English version and make sure that both versions match in signatories and dates, in addition to the modified text.

By Docusign (preferable, IBSAL has Docusign), MSB or Adobesign. Mixed digital signature methods are not supported.

The Foundation prefers that this management be carried out by the Promoter/CRO through its own means (cab companies, specialized companies, etc.). If finally the promoter/CRO cannot carry out this management and delegates it to the IBSAL, it is specified in the contract and in the economic report; the promoter has to take into account that he/she will have to pay the IBSAL the expenses of this management, which are 10% additional to the amount that will be reimbursed to the patient.

Until the overload of tests in the Radiology Department decreases, only MRI-MRIs should be outsourced (for more information, contact ensayosclinicos@ibsal.es). This does not apply if the MRI is performed in the Cardiology imaging unit.

The one included in accordance with the Annex to the Model Insurance Certificate published by the AEMPS on its website and:

  • For clinical trials within the Complejo Asistencial Universitario de Salamanca (CAUSA):

    Dr. /Dr. Principal Investigator

    Complejo Asistencial Universitario De Salamanca

    Foundation Institute of Health Sciences Studies of Castilla y León-Institute of Biomedical Research of Salamanca (IBSAL)

    Pº San Vicente, 58-182 37007 Salamanca
  • For clinical trials in Primary Care Health Centers:

    Dr. /Dr. Principal Investigator.

    Health Center (Name)-Gerencia de Atención Primaria

    Foundation Institute of Health Sciences Studies of Castilla y León-Institute of Biomedical Research of Salamanca (IBSAL)

    (Address of the health center) Salamanca

  • For clinical trials in Psychiatry (depending on Specialized Care) carried out in Health Centers:

    Dr. /Dr. Principal Investigator.

    Psychiatry Service

    Complejo Asistencial Universitario De Salamanca

    Foundation Institute of Health Sciences Studies of Castilla y León-Institute of Biomedical Research of Salamanca (IBSAL)

    Health Center (Name)

    (Address of the health center) Salamanca

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Hospital Virgen de la Vega, 10th Floor.

Paseo de San Vicente, 58-182.
37007 Salamanca

+34 923 29 11 00
Ext. 55113

secretaria@ibsal.es

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IBSAL is one of the 35 Biomedical Research Institutes accredited by the Instituto de Salud Carlos III and the only one of its kind in Castilla y León. Order of February 17, 2014, of the Secretary of State for Research, Development and Innovation.

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