The Italian Medicines Agency (AIFA) has provided the following specific indications for the management of clinical trials in Italy during the COVID-19 emergency, valid until further notice.
- Submission of clinical trials and substantial amendments
- If the CTA/amendment request is submitted through the OsSC portal, the submission of paper documents/CD-rom can be postponed. It is recommended, whenever possible, to apply the duty stamp on the transmission letter by virtual payment and to digitally sign the letter uploaded in the OsSC.
- In case the submission via OsSC is not possible and paper transmission is needed, the transmission by e-mail will not be accepted. Exception is made only for the submission of clinical trials regarding treatment of COVID-19 (coronavirus disease 19).
- Ethics Committees evaluations of clinical trials/substantial amendments
Ethics Committees meetings are not suspended but they will be managed through web-conferences or other telematic procedures.
- Management of clinical trial activities outside investigational sites
If necessary and where feasible, in order to supply patients with the investigational drug(s) to avoid them going to the hospital or carry out other activities related to the clinical trial (e.g. visits and exams or adverse reactions management) at patient’s home or in a site different from the investigational clinical site, Sponsors will have to notify a substantial amendment for immediate implementation only to the Ethics Committees involved, indicating its urgency due to the current emergency.
Sponsors/CROs are invited to draw up a risk evaluation plan and implement an action plan for the maximum protection of the subjects, also in view of the urgent need to minimize contacts between patients and investigational staff, and not to overload healthcare facilities.
Some exemptions, limited to this emergency period, are provided for:
- Investigational Medicinal Product (IMP) management
- Clinical examinations
- Sites closing
- Clinical Trial monitoring
- Activities related to clinical management of patients falling under Principal Investigator’s (PI) responsibility
- Expenses reimbursement
For more details you can find the full notice at the following link:
Regulatory Pharma Net is available to provide full support for any query and for the submission of Clinical Trial Applications and the relevant amendments.