This press release is to inform OsSC contact persons that the Register of Observational Studies (Registro degli Studi Osservazionali, hereinafter RSO) will be activated on 31 January 2023.

The legal basis for the RSO is Art. 6 of the Ministerial Decree of 30.11.2021 'Measures to facilitate and support the conduct of non-profit clinical trials of medicinal products and observational studies and to regulate the transfer of data and results of non-profit trials for registration purposes, pursuant to Art.1, paragraph 1, letter c), of Legislative Decree No. 52 of 14 May 2019" (Italian Official Gazette G.U. No. 42 of 19 February 2022) and, pending the publication of the new guidelines referred to in the same article, Article 2 of the "Guidelines for the classification and conduct of observational studies on medicines" of 20 March 2008 (Italian Official Gazette G.U. No. 76 of 31 March 2008).

The operating procedures for the functioning and use of the RSO are detailed in this press release.
The RSO represents the management tool envisaged by the regulations in force and is complementary to the National Observatory on Clinical Trials (Osservatorio Nazionale sulla Sperimentazione Clinica - OsSC), i.e. the management tool for interventional clinical trials, with which it also shares the registries.

Access to the RSO
To access the RSO website, similarly to OsSC, it is necessary to connect to AIFA's Online Services Portal available at the following website address: https://servizionline.aifa.gov.it/
A direct link will be available in the Research and Clinical Trials section of AIFA website.

Sponsors and CROs area
Study protocol (telematic dossier)
Registration is compulsory only for new applications (paper application/notification) whose letter of transmission to the Ethics Committee is subsequent to 1 January 2023. With regard to studies on COVID-19, all studies submitted to the Ethics Committee since the start of the pandemic should be registered.

Registration for all studies is limited to the initial application. For studies submitted to the Ethics Committee after the publication of this press release, the entry into the RSO must occur at the same time as the paper submission to the Ethics Committee. Any changes to the study data (amendments), including the subsequent addition of local clinical centres, do not require an update of the dossier.
Study start, end and results

Data on the start (in the first centre) and the end in full of the study in Italy must be submitted within 30 days of the start/end of the study.

A summary of the study results must be sent within 12 months of the study end (for international studies, this means global trial end).

Ethics Committees Area
Ethics Committees are required to enter the data that fall within their competence into the RSO within 30 days of the decision or receipt of the paper application:
•    protocol evaluation, for prospective cohort studies or studies evaluated by the Ethics Committee (if required by local procedures);
•    date of receipt of the paper application (acknowledgement), for notified studies.
Ethics Committees involved after the first submission of the telematic dossier will not be able to access the RSO to send data.

External Users Area
The new RSO system will allow external users - who have registered to AIFA online services - to search and consult observational studies of their own competence and/or interest (e.g. Regions, citizens/patients).

Tools and support services
Please consult the attached Manuals, which are also available within the application, based on the user profile.

For procedural or regulatory issues, please contact AIFA by sending an e-mail to info_rso@aifa.gov.it
For technical issues, please contact the HelpDesk helpdesk@aifa.gov.it 

Published on: 22 December 2022
Last updated on: 03 February 2023