Insights

As of December 4, 2025, the Registro Studi Osservazionali (RSO) platform has been enhanced to comply with AIFA’s updated Guideline for the Classification and Conduct of Observational Drug Studies (Det-Pres-425-2024).

Here are the key new functionalities:

1. Implementation of the Single Ethics Committee (CET/CEN) for all studies, regardless of design or direction (prospective or retrospective).
2. Retrospective and cross-sectional studies now undergo full evaluation, with the option to request integrations—eliminating the “acknowledgment” phase.
3. Expanded document upload functionality: cover letters, synopsis, center list, informed consent, etc., in line with Section 14 of the Guideline.
4. Off-label drug usage can now be included exclusively for retrospective studies, supporting analyses of compassionate use or non-authorized indications.
5. Organizational-level visibility and operability: All users within the same organization can now access and manage studies collaboratively.

These changes significantly streamline the submission and evaluation process, aligning national operations with the current regulatory framework and ensuring greater consistency across observational study submissions.

RPN will provide any further update and is available to provide full regulatory support for Clinical Trials