The National Monitoring Centre on Clinical Research with Medicines
[Acknowledgements: Prof David Hutchinson. Principal Author & Editor of Advisor]
[NOTE – The following does NOT apply to observational studies]
The National Monitoring Centre on Clinical Research with Medicines (Osservatorio Nazionale sulla Sperimentazione Clinica con i Medicinali; OsSC) monitors ongoing clinical trials in Italy. The Italian Medicines Agency (AIFA) has announced changes to the functionality of its systems in order to enhance the authorisation of clinical trials in Italy.
OsSC collects and evaluates trial data, establishing qualitative and quantitative trends over time and reporting them via periodic publications. More recently, the OsSC has been able to edit applications for the authorisation of clinical trials in a format consistent with EU rules, and to evaluate the opinions of ethics committees in a standard format.
Applicants and ethics committees can already access the new functionality within OsSC and, from 1 October 2014, the e-submission process should be used prospectively for all new clinical trial authorisation applications and for any amendments. Requests for the authorisation of amendments to clinical trials that are already in progress will continue to be managed using the transitional arrangements. Guidance on how to use OsSC is available from the AIFA Portal of Clinical Research with Medicines.
Clarification from AIFA on Applicability to Observational Studies
[Personal communication dated 1-SEP-2014]
OsSC applies only to interventional clinical trials.
Regarding to the observational studies, as indicated in the note of April 30th, 2013 (http://www.agenziafarmaco.gov.it/it/content/chiarimenti-procedural-on-OsSC-e rso-30042013 ), the applicant must submit to AIFA the modules for the initial registration and conclusion of the study to the email address email@example.com . It is not required to send paper (https://www.agenziafarmaco.gov.it/ricclin/sites/default/files/files_wysiwyg/files/Normativa/DETERMINAZ_AIFA_20_Marzo_2008_ST_OSS.pdf ). The modules referred to above can be found at the following address: http://www.agenziafarmaco.gov.it/it/content/nuovi-sistemi-informativi-aifa-e-adempimenti-relativi-sperimentazione-clinica-aggiornamenti- .