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.
Los modelos de contrato están aprobados por la Generalitat Valenciana
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.
Estudio observacional con producto sanitario: Investigaciones clínicas realizadas con productos sanitarios que ostentan el marcado CE en condiciones normales de utilización, las prestaciones de los productos corresponden a las atribuidas por el fabricante
- Real Decreto 192/2023, de 21 de marzo, por el que se regulan los productos sanitarios.
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DOCUMENTACIÓN
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1. Protocolo EO-PS
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2. Memoria económica EO-PS
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3. Compromiso Persona Investigadora Principal (*)
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4. Informe CEIm
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5. Delegación de responsabilidades (cuando hay CRO)
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6. Hoja informe al paciente y Consentimiento informado
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7. Relación del equipo de investigación EO-PS (*)
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MODELOS CONTRATOS
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Modelo Contrato EO-PS
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Modelo Contrato EO-PS (Bilingüe)
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OTROS MODELOS
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Modelo ADENDA EO-PS cambio IP
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Modelo ADENDA EO-PS cambio IP y ME
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Modelo ADENDA EO-PS cambio ME
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Modelo ADENDA EO-PS cambio ME (Bilingüe)
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Modelo ADENDA EO-PS otro cambio
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Modelo ADENDA EO-PS cambio promotor (Bilingüe)
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Modelo FE DE ERRATAS EO-PS
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Modelo Solicitud EXENCIÓN DE TASAS EO-PS
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Modelo NOTA Cambio equipo investigación
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DOCUMENTACIÓN
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1. Protocolo EO
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2. Memoria económica EO
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3. Compromiso Persona Investigadora Principal (*)
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4. Informe CEIm
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5. Delegación de responsabilidades (cuando hay CRO)
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6. Hoja informe al paciente y Consentimiento informado
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7. Relación del equipo de investigación EO (*)
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MODELOS CONTRATOS
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Modelo Contrato PROYECTO DE INVESTIGACIÓN
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Modelo Contrato otros estudios clínicos
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Modelo Contrato otros estudios clínicos (Bilingüe)
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Modelo Solicitud EXENCIÓN DE TASAS EO
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(*) Los documentos deben enviarse en archivo Word a la persona gestora de EECC (eecc@isabial.es), ella tramitará las firmas electrónicas con los firmantes correspondientes.
Contact
David Pavía 965 913 921
María Lafuente 965 913 989
Location
5th Floor, Diagnostic Center (Grey Building)
Dr. Balmis University General Hospital
Avda.Pintor Baeza, 12, 03010 Alicante Pintor Baeza, 12, 03010 Alicante
Hours
Monday to Friday
9:00 AM to 2:30 PM