Clinical trials

General Information study start-up

Expression of Interest in Participating in Clinical Studies

The Clinical Research Unit of IRBLleida facilitates collaboration with sponsors, CROs, and other stakeholders involved in clinical trials with medicinal products, observational studies, and clinical research involving medical devices.

If you would like to express interest in participating in a study, please send your request by email to:

afemandez@irblleida.cat / ensayos@irblleida.cat

Information Required in Your Request

• Study protocol
• EudraCT number (if applicable)
• Therapeutic area

Upon receipt of your request, our team will contact the clinical investigators to confirm their availability and interest in participating.

Contract Management Procedure

In accordance with current regulations governing clinical studies, clinical trials with medicinal products, observational studies, and clinical research involving medical devices must have a contract signed by the sponsor, the study site, and the managing entity before the study can begin. This contract establishes the responsibilities of each party involved in the conduct of the study and sets out its financial arrangements.

Once all parties have agreed to the conduct of the clinical study and the necessary regulatory approvals have been obtained, the Clinical Studies Management Unit of IRBLleida will proceed with contract management and the review of the study budget. These reviews may also be carried out in parallel with the process of obtaining the relevant authorizations.

Documentation required for contract management:

• Study protocol
• Study budget
• Sponsor's insurance policy certificate, where applicable

The Clinical Studies Management Unit will maintain the confidentiality of all information received as confidential and will ensure that all personnel with access to such information comply with this commitment.

In parallel with contract negotiations, the Principal Investigator will be contacted internally to define the study team, request authorizations from the departments involved, and adapt the study budget as required.

Signature Process

Once the contract has received final approval, the Clinical Studies Management Unit of IRBLleida will initiate the signature process involving all relevant parties, thereby completing the contract formalization procedure.

Following formalization of the agreement, the study may be activated at the study site.