Clinical trials management in Italy during the COVID-19 emergency

The Italian Medicines Agency (AIFA) has recently provided some guidelines regarding the management of clinical trials in Italy that will be valid until further notice: the document can be found at this link.

First of all, the postponement of paper documentation and CD-rom sending regarding the authorization requests for clinical trials and substantial amendments submitted by the OsSC is allowed; if submission is not possible and paper transmission is needed, procedure by e-mail is not permitted. There is only one exception: authorization requests by e-mail to are allowed for the submission of clinical trials for the treatment of COVID-19.

Dedicated advice is available for the management of Investigational Medicinal Products (IMP)Clinical examinations (hematological tests must be carried out in public health structures or in private sites recognized eligible pursuant to the Ministerial Decree of 19th March 1998), emergency situations due to sites closing and in-situ monitoring visits.

Lastly, it is pointed out that the Sponsor, as an extraordinary measure limited to the coronavirus emergency, may sign contracts directly with specialized agencies/companies for the clinical management of patients’ activities (under the responsibility of the Principal Investigator – PI). Furthermore, it is specified that exceptional expenses for the protection of subjects involved in clinical trials may be reimbursed.