Did you remotize your clinical trial during COVID-19 pandemic?
Given the numerous requests received from the research stakeholders to the Clinical Trials Office and to the GCP Inspection Office, the Italian Medicines Agency (AIFA) provided indications on the management of clinical trials and the introduction of substantial amendments in Italy following the exceptional restrictive measures introduced by the government during the COVID-19 pandemic.
Clinical operations outside of the investigational site
Sponsors and investigators have been encouraged to avoid unnecessary trial-related visits, elaborating a plan to control infective risk in enrolled subjects.
According to this guideline, home-healthcare procedures may be scheduled and carried out, under the supervision on the PI, by the Sponsor/ Promoter of the investigation, investigational site personnel, external provider.
Remote Source Data Verification
To reduce at-risk direct contacts, monitoring plan can be designed or adapted to include remote visits for SDV or to delay visits.
Remote SDV can be carried out through videoconference with the visualization of source documents, phone calls or through sharing platforms and clouds. Exceptionally and temporarily, the monitor can obtain the access to the electronic medical records.
Alternative methods to obtain the informed consent
To avoid unnecessary presence of the study subjects at the site, remote or alternative methods can be used to inform the patient about the clinical trial procedures and to obtain consent.
Electronic Consent (eConsent) can be obtained by using electronic signature or through videoconference or phone call.
A full informative to the patient can be easily delivered with the Video-assisted Informed Consent (VIC)