New functionalities activated in the Registry of Observational Studies (RSO)

As of 4 December 2025, the new functionalities implemented in the Registry of Observational Studies (RSO) are active, with the aim of aligning the system’s operational workflows with the new Guideline for the classification and conduct of observational studies on medicinal products – Det‑Pres‑425‑2024 (hereinafter AIFA Guideline), available at the link: Attivazione_nuove_funzionalita_RSO_04.12.2025

The new functionalities implemented in the RSO platform are the following:

1) implementation of the single Ethics Committee (CET/CEN) for all studies regardless of directionality and study design (prospective or otherwise)

2) maintenance, for retrospective/transversal studies, of the evaluation — as the sole option — and elimination of the acknowledgement, providing the possibility to request integrations similarly to what already applies to prospective studies

3) upload of additional documents beyond the protocol (cover letter, synopsis, list of centres, informed consent, etc.) in accordance with the AIFA Guideline, and increase in the size of each individual document that can be uploaded

4) possibility to enter off‑label medicinal products for retrospective studies only

5) visibility of the studies and related operability for all users belonging to the same Organisation