CASubmissionFormat object
Format option(s)
post (in paper form with CD-ROM) or electronically (via e-mail to the following address: dgfdm@postacert.sanita.it)
Standard application form available
Yes
Standard application form
The online form is available on the Ministry of Health website for Notification of clinical trials:
(1) with CE-marked MD (post market): Home > Ministro e Ministero > Moduli e servizi online > Comunicazione di avvio indagini cliniche post market > Moduli.
(2) with non-CE-marked MD (pre market): Home > Ministro e Ministero > Moduli e servizi online > Notifica di indagini cliniche svolte con dispositivi medici non recanti la marcatura CE (pre market) > Moduli.
