Italy

DCT Feasibility Assessment Italy The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This workbook provides an overview of the current and proposed regulatory landscape applicable in Italy in relation to Decentralized Clinical Trials (“DCT”). It supplements the regulations applicable to the EU and EEA described in the European Medi...

2.1 Name of Regulatory Authority Italian Medicines Agency/Agenzia Italiana del Farmaco (“AIFA”) AIFA , the competent authority in Italy, is responsible for all aspects concerning the investigation (authorization and monitoring of clinical...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   As per Art 2(5) of the Ministry of Health Decree 27 Jan 2023 : “The documentation r...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The following electronic documents are required to be submitted via CTIS (the EU’s Clinic...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   The sponsor must submit an application to the Ethics Committee competent for the clinical site, which will include details of the pr...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. The TARIC (Tarif Intégré de la Communauté) assists with determining if a license is required for a particular product. The TARIC is a multiling...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/guidance on the use of DCT el...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Primarily, the GDPR and the Italian Data Protection Code (DPC) (Legislative Decree no.101 of 10 Aug 2018) need to ...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ?   Yes , subject to compliance with the appropriate EMA rules. No natio...

10.1 Clinical Trial with Investigational Medicinal Product The submission process using CTIS is described in more detail below this flowchart/road map: Training is to be prioritized for relevant staff in Italy on the use of the Clinical...

Europe EU Clinical Trial Regulation (EU CTR) 536/2014 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131   EMA- Questions and Answers Document Regulation (EU) 536/2014 https://health.ec.europa.eu/medicina...

 Not applicable.