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.
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DOCUMENTACIÓN
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1. Protocolo EOM
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2. Memoria económica EOM
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3. Compromiso Persona Investigadora Principal (*)
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4. Informe CEIm
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5. Autorización CAEPO (con seguimiento prospectivo, con ánimo comercial)
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6. Delegación de responsabilidades (cuando hay CRO)
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7. Hoja informe al paciente y Consentimiento informado
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8. Relación del equipo de investigación EOM (*)
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MODELOS CONTRATOS
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Modelo Contrato EOM con seguimiento prospectivo
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Modelo Contrato EOM con seguimiento prospectivo bilingüe
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Modelo Contrato EOM con seguimiento NO prospectivo
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Modelo Contrato EOM con seguimiento NO prospectivo bilingüe
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OTROS MODELOS
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Modelo ADENDA EOM cambio IP
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Modelo ADENDA EOM cambio IP y ME
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Modelo ADENDA EOM cambio ME
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Modelo ADENDA EOM cambio ME (Bilingüe)
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Modelo ADENDA EOM otro cambio
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Modelo FE DE ERRATAS EOM
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Modelo Solicitud EXENCIÓN DE TASAS EOM
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Modelo NOTA cambio equipo de investigación
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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