The Observational Studies Register (RSO) is the management tool required by current legislation for this type of study.

Following the publication of the new Guideline for the classification and conduct of observational studies on medicines, the information relating to the RSO, activated on 31 January 2023, is updated as detailed in the document “RSO provisions update” and related Annexes 1 and 2.

Access to the RSO

In order to access the RSO website, it is necessary to connect to AIFA's Online Services Portal.

Promoters and CRO Area

Pharmacological observational studies meeting the requirements of the current Guideline for the classification and conduct of observational studies on medicines have to be registered in the RSO, regardless of the direction and design of the study.

Non-pharmacological observational studies do not need to be registered.

Ethics Committees Area

Ethics Committees are required to enter their own data into the RSO within 30 days of the decision on protocol evaluation, in the case of prospective, retrospective and bidirectional cohort studies.

External Users Area

The new RSO system will allow external users (e.g. Regions, citizens/patients), after registering with the AIFA Online Services, to search for and consult observational studies of their own competence and/or interest.

Support tools and services

Please consult the Manuals attached and also available within the application, depending on the user profile.

For procedural or regulatory issues, please contact AIFA by sending an email to info_rso@aifa.gov.it.

For technical issues, please contact the HelpDesk Service.