Clinical trials

To initiate a study at the Alicante Department of Health – General Hospital, it is essential that a contract signed by all involved parties is in place beforehand.

El modelo de contrato será el estipulado en la <<RESOLUTION of 16 July 2009 of the Regional Ministry of Health, approving the model contract to be entered into between the management of a healthcare center, the sponsor, and the investigators for the conduct of a clinical trial or post‑authorization observational studies of medicinal products and medical devices within the healthcare service organizations of the Valencian Community>>.

These templates, being regulated by regional legislation, DO NOT ALLOW MODIFICATION, only COMPLETION.

The sponsor / CRO is responsible for completing all the basic study-related information, the financial details, and the relevant annexes. Once the draft contract has been filled in, it must be sent by email to the designated contact person in charge of contract management, so that they can proceed with its validation.

The contract signing process begins once approval has been granted by the ISABIAL Management Foundation, which generates the PDF document and sends it to the Sponsor / CRO so that they may digitally sign it or sign the three hard copies and initiate the signature circuit (digital and/or handwritten). Once the contract has been signed by the Sponsor / CRO, it is returned to the ISABIAL Management Foundation, after which the signatures of the principal investigator, the Manager of the Alicante General University Hospital, and the Director of the ISABIAL Management Foundation are completed. Once all signatures have been obtained by ISABIAL, the Sponsor is notified so they can arrange for a courier to collect their original copy. If all signatures are digital, the contract will be sent by email.