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.

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

Name of applicant including CRO/Promoter:

E-mail address

Title

Protocol code

EUCT Number

Principal Investigator

Invoice payable to:

Complete address:

TAX ID/CIF

Contact telephone number

Mailing address for sending invoice:

Completed CAUSA / Primary Care Form

Summary of the protocol

Remarks

I have read and accept the privacy policy

EECC/ICPS/EEOO Contract Negotiation Initiation Form

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

Name of applicant including CRO/Promoter

E-mail address

Protocol code

Internal contract ref code

Other identifiers

Principal Investigator

Invoice request documents

Remarks

I have read and accept the privacy policy

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. The contract template includes a suspensive clause that allows for this. Once the Sponsor/CRO has these documents, they must submit them to contract.clinicaltrials@ibsal.es

Is another model contract proposed by the Developer acceptable?

Is there an addendum model?

Yes

Is there any payment to initiate, manage or sign the contract or addendum?

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).

Is there a model contract in English?

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.

Is the digital signature of the promoter allowed in the contract?

Via DocuSign (preferred; IBSAL uses DocuSign) or Adobe Sign. Mixing different digital signature methods is not permitted.

Does IBSAL reimburse patients for extraordinary expenses?

The Foundation prefers that the sponsor/CRO handle this process using its own resources (taxi companies, specialized firms, etc.). If the sponsor/CRO is ultimately unable to handle this process and delegates it to IBSAL, this must be specified in the contract and in the financial report; the developer must bear in mind that it will be required to pay IBSAL the costs associated with this process, which amount to an additional 10% of the amount to be reimbursed to the patient.

Is it necessary to outsource tests to be performed in the trial?

MRI scans that are to be performed in the Radiology Department must be outsourced. This does not apply if the MRI is performed in the Cardiology Imaging Unit. Sponsors and CROs must also outsource ophthalmology tests due to the Center’s heavy workload with this type of testing.

What information should be included in the insurance certificate?

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

For clinical trials conducted at the Salamanca University Healthcare Complex (CAUSA):
Dr. Principal Investigator
Complejo Asistencial Universitario De Salamanca
Salamanca Biomedical Research Foundation (FIBSAL)—Salamanca Biomedical Research Institute (IBSAL)
Paseo de San Vicente, 58-182, 37007 Salamanca

For clinical trials at primary care health centers:
Dr. Principal Investigator
Health Center (Name)-Gerencia de Atención Primaria
Salamanca Biomedical Research Foundation (FIBSAL)—Salamanca Biomedical Research Institute (IBSAL)
Pº San Vicente, 58-182 37007 Salamanca

(Address of the health center) Salamanca

For clinical trials in psychiatry (under the Specialized Care category) conducted at health centers:
Dr. Principal Investigator
Psychiatry Service
Complejo Asistencial Universitario De Salamanca
Salamanca Biomedical Research Foundation (FIBSAL)—Salamanca Biomedical Research Institute (IBSAL)
Pº San Vicente, 58-182 37007 Salamanca

Health Center (Name)
(Address of the health center) Salamanca