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Italian Medicines Agency Agenzia Italiana del Farmaco

National Observatory on Clinical Trials

National Observatory on Clinical Trials

The National Observatory on Clinical Trials (OsSC) manages the authorisation process of clinical trials (Phase I-IV) that are conducted in Italy, and provides a real time picture of the clinical research progress in the country. It also acts as an interface for transferring information to the European EudraCT database.

It allows to submit applications for clinical trials and for substantial amendments to clinical trials already initiated, including all related documentation, at the same time to AIFA, as the competent authority, and to the coordinating ethics committee, as well as to all reference ethics committees for each trial.

At European level, the OsSC represents a model of e-submission platform, workflow and database on clinical trials concerning medicinal products, both in terms of telematic management of authorisation and documentation flows between Regions, competent authorities, ethics committees, promoters, contract research organisations, clinical centres and the European EudraCT database, and in terms of information periodically addressed to operators and citizens through the National Report on Clinical Trials.

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Registro nazionale centri clinici e Comitati etici

Uffici di riferimento

Reference offices

Clinical Trials Office

Donatella Gramaglia

d.gramaglia@aifa.gov.it

Pre-Authorisation Division

Sandra Petraglia

s.petraglia@aifa.gov.it

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