January 2023: Update on Italy’s Register of Observational Studies

On December 22, 2022, a press release about the Register of Observational Studies (RSO) was posted on the website of the Italian Medicines Agency (AIFA).

On January 31st, the Register of Observational Studies (RSO) will go live.

In the press release, the following operational procedures and RSO usage were described in detail:

Access to the RSO

To access the RSO website, the sponsors need to connect to the AIFA Online Services Portal available at the web address: https://servizionline.aifa.gov.it/.

Promoters and CRO area

  • Registration on RSO is mandatory only for new requests (paper application/notification), whose letter of transmission was submitted to the Ethics Committee (EC) after 1 January 2023.
  • For studies submitted to the EC after the publication of this press release, inclusion in the RSO must be carried out at the same time as the paper submission to the EC.
  • The initiation data (in the first center) and completion of the study in Italy must be submitted within 30 days of the opening/conclusion of the study
  • A summary of the study results should be submitted within twelve months of the conclusion of the study.

Ethics committee area

  • The ECs are required to enter the data within their competence in the RSO within 30 days of the decision or receipt of the paper application

External users’ area

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

Support tools and services

AIFA has provided email addresses for regulatory ([email protected]) and technical support ([email protected]).

The press release also provides links to the following guidance manuals for more details

Manual – Ethics Committee Profile

Manual – External User Profile

Manual – Applicant User Profile

Further details can be found here.