National Monitoring Centre for Clinical Trials

Osservatorio Nazionale delle Sperimentazioni Cliniche (OsSC): what is this and how does it work?

The Osservatorio Nazionale sulla Sperimentazione Clinica con i Medicinali – OsSC (National Monitoring Centre on Clinical Research with Medicines) is a technical and scientific tool aimed at guaranteeing the epidemiological surveillance of clinical trials with medicines  carried out in Italy and at monitoring the qualitative and quantitative trend of trials over the course of years. Since 2000, when OsSC was established by the Ministry of Health, it has been collecting and analysing the data of clinical pharmacological trials and periodically publishes reports. Furthermore, according to a ministerial decree recently issued, the OsSC has become a tool to edit the applications for the request of authorisation for a clinical trial in the format provided by current rules within the European Union and to edit the opinions of the Ethics Committees in a standard format.

Actually, OsSC project involves the Clinical Trials Office of the Italian Agency of Medicines  (AIFA) and an IT team of the Consorzio Interuniversitario per il Calcolo Automatico (CINECA) which has developed the project and is responsible for its technical maintenance. Data entry activity has been mainly entrusted to Sponsors, CROs (Contract Research Organisations, when working on behalf of sponsors), Ethics Committees responsible for the assessment of clinical trial applications and documents as well as to Istituto Superiore di Sanità and AIFA with respect to clinical trials falling within their competence.

For Sponsors OsSC is a fast means of contacting Ethics Committees and submitting to them the initial application form (CTA form) and the electronic version of the documents attached (protocol, Investigator’s Brochure, informed consent form etc.) as well as all the other information necessary for assessment, including the following applications for possible substantial amendments.

The activities of the OsSC aim at monitoring and analysing the clinical trials with medicines and, as a consequence, at carrying out publishing initiatives through which the data entered are processed and sorted according to macro categories and then dispensed to the OsSC users, to professionals of this sector and to general public. These publishing activities accomplish through the edition and publication of specific reports based upon national and regional data.