Clinical Trials

In Italy the clinical trials are regulated by a legislative decree, entered into force in January 2004 (Decreto legislativo 24 giugno 2003, n.211).
This decree transposes the Directive 2001/20/CE concerning the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
The above mentioned decree has integrally implemented the European directive and it has also anticipated a few additional provisions issued in order to better regulate the responsibility and the role of the Ethics Committees and to give instructions about the type of information to be submitted through the database of the Osservatorio Nazionale della Sperimentazione Clinica - (National Monitoring Centre of Clinical Trials).
The annual number of clinical trials in Italy since 2000 has steadily grown. Since 2000 the “Annual Reports on clinical trials” are public available.

Submission procedures

The submission of the clinical trial application data and supporting documents must be done through the National Clinical Trials Monitoring Centre Database (Osservatorio – OsSC).  The sponsor must submit these data mainly in Italian except for free text core data set, where English language is required. Information required are compliant with the Ministerial decree 21^st December 2007 “Modalità di inoltro della richiesta di autorizzazione all’Autorità competente, per la comunicazione di emendamenti sostanziali e la dichiarazione di conclusione della sperimentazione clinic a e per la richiesta di parere al comitato etico”.
To access the OsSC, the sponsor/C.R.O. should obtain a user ID/password.
To request the user ID/password, it is necessary to connect with the web-site of OsSC and follow the instructions.
The registration of the trial data and documents within the OsSC complies with the Italian and European requirements (EudraCT DB) for Clinical Trial electronic data transmission to the Competent Authority. Blank copies of the CTA form to apply for authorisation and  Ethics Committee opinion are available in the OsSC.
For further details, please consult the FAQ section.

Competent Authorities

The Italian Medicines Agency – AIFA - is the Competent Authority for clinical trials using:

• gene therapy,
• somatic cells therapy and
• IMPs containing GMO.

Application forms and supporting documents have to be sent to the Ufficio Sperimentazione Clinica of AIFA.
E-mail: sperimentazione.clinica@aifa.gov.it

The National Institute of Health (Istituto Superiore di Sanità - ISS) is the Competent Authority for phase I clinical trials.
Further information and contact details are available at the website.
Application forms and supporting documents have to be sent to the following address:

For all the other clinical trials, and namely, for those that are neither phase I trials nor trials testing gene/somatic cells/GMO therapies, authorisation has to be requested from the local Competent Authority of each clinical site (that is the legal Officer: i.e. director general of the Hospital). The legal Officer can authorise the trial within 60 days. If the legal Officer has not informed the applicant of any grounds for non-acceptance within 60 days, the trial is considered authorised, provided that the opinion of the Ethics Committee is favourable. Timeframe is reduced to 35 days for the authorisation/no grounds for non acceptance of any substantial amendment.
Practically, the local Competent Authority is involved in administrative evaluation of the financial agreement. The local Competent Authority (the legal Officer of each clinical site) usually delegates the complete scientific assessment of the trial to the Ethics Committee of its facility.
The central Competent Authority (AIFA) performs only a marginal assessment of all the clinical trials employing therapies which do not fall within its competence (see section 2.1) involving only a check of the data before transmission to EudraCT database and a check of suspected serious adverse reactions (SUSARs). The assessment of the complete clinical trial application and documents is performed by accredited Ethics Committees.

Contacts

	Research and Clinical Trials Head of Office: Carlo Tomino Phone: +39 06 5978 4474 Fax: +39 06 5978 4110 E-mail: c.tomino@aifa.gov.it
	Good Clinical Practice Inspectorate Head of Office: Umberto Filibeck Phone: +39 06 5978 4073 Fax: +39 06 5978 4149 E-mail: u.filibeck@aifa.gov.it