Starting from January 31st, 2023 the Registry of Observational Studies (RSO) will be activated on the AIFA Portal.
The RSO is the management tool required by current legislation and it is complementary to the National Observatory on Clinical Trials (OsSC) for interventional clinical trials.
This system will enable the submission of the authorization request for an observational study to the involved Ethics Committee, subject to the registration to the system.
The submission through this new tool is limited to the initial request and it is mandatory only for new applications submitted from January 1st 2023 with exception for the observational studies on COVID-19 for which it is recommended to proceed with the registration of all studies submitted to the Ethics Committee since the start of the pandemic.
Any changes to the study data (amendments), including the subsequent addition of clinical sites, do not require an update of the study dossier.
Moreover, the new RSO system will allow external registered users to search and consult observational studies.
For more details you can find the full notice at the following link: https://www.aifa.gov.it/en/-/registro-degli-studi-osservazionali-rso-attivazione-a-partire-dal-31-gennaio-2023
RPN is ready to provide support with the registration to this new AIFA Registry and for any submission of authorization requests for observational studies.