Following the Legislative Decree n.18 of 17/03/2020, AIFA has published a Circular indicating the simplified procedures for the data acquisition as well as the methods for joining the studies for the COVID-19 treatment.
The authorization requests shall be submitted to AIFA and National Ethics Committee of INMI Spallanzani (EC) through the OsSC platform. However, if there are some technical OsSC issues the following approaches are accepted:
- paper submission
- submission via certified email (PEC)
The observational studies shall be submitted by e-mail in parallel to AIFA and EC.
In order to speed up the assessment process, it is advisable to submit the proposals both for clinical trials and observational studies by using the specific form made available by AIFA.
The wording “COVID-19” should be reported in the subject of any communications.
For more details you can find the full notice at the following link: https://www.aifa.gov.it/en/web/guest/-/circolare-sulle-procedure-semplificate-per-gli-studi-e-gli-usi-compassionevoli-per-l-emergenza-da-covid-19
RPN constantly monitors the AIFA website in order to stay up to date on clinical trials and observational studies and it is available to provide full support for any query and for the submission of Clinical Trial Applications and relevant amendments as well as for the notifications of observational studies.