• INTERVENTIONAL CLINICAL TRIAL

The Ethics Committee must be consulted for the assessment of interventional clinical trials with every type of biomedical technology (drugs, medical devices, surgery technique, diagnostics, etc.) or other type of intervention (care, training, etc.).

The favourable opinion of the Ethics Committee is mandatory and binding, and must be obtained before the start of trial together with the opinion of competent authority.

All documentation to submit may be requested to the Clinical Research Unit and is available at the following link: https://www.aovr.veneto.it/area-scientifica/comitati/comitato-etico-per-la-sperimentazione-clinica

  • EPIDEMIOLOGICAL/OBSERVATIONAL TRIALS

The Ethics Committee must be consulted for the assessment of the observational/epidemiological trials.

In compliance with current legislation the Ethics Committee:

→ gives an OPINION in case of observational/epidemiological trial that involves directly the patient or provides for access to his/her sensitive data by the medical researcher

→ simply TAKES NOTE of the observational/epidemiological retrospective trials that collect clinical or administrative data without involving patients.

The submission modalities of documentation are the same of interventional clinical trials. All documentation to submit may be requested to the Clinical Research Unit and is available at the following link: https://www.aovr.veneto.it/area-scientifica/comitati/comitato-etico-per-la-sperimentazione-clinica

  • THERAPEUTIC USE OF DRUG UNDER CLINICAL TRIAL (FORMER COMPASSIONATE USE)

In according with the national (Decree 7th September 2017 of Italian Health Ministry “Disciplina dell’uso terapeutico di medicinale sottoposto a sperimentazione clinica. “) and regional legislation (Deliberation of the Veneto Region Government n.4284 of 29th December 2004: “Disposizioni in merito all’uso terapeutico di medicinali sottoposti a sperimentazione clinica nella Regione Veneto”) the Ethics Committee must be consulted to approve the use protocols of medicine products under clinical trial to use them outside the clinical trial when there is no valid therapeutic alternative.

All documentation to submit may be requested to the Clinical Research Unit and is available at the following link: https://www.aovr.veneto.it/area-scientifica/comitati/comitato-etico-per-la-sperimentazione-clinica