Remote GCP Inspections May Be More Demanding Than On-Site Inspections, Says EMA Guidance
Remote good clinical practice (GCP) inspections of a trial site and/or sponsor may be necessary during the COVID-19 health crisis, according to new guidance from the European Medicines Agency (EMA), but inspection teams should recognize that preparation of remote GCP inspections will be more demanding than on-site inspections as it will require early communication with the sponsor to determine whether a remote inspection is feasible.
Sites/sponsors will also need to meet requirements for providing remote access to electronic systems while maintaining communication and support to inspectors, according to the guidance. Inspectors as well as the sponsor and/or site should be granted remote access to electronic case report form (eCRF) systems and should be able to review electronic trial master file (eTMF) audit trails, activity logs and metadata during inspections.
Despite the appropriateness of remote inspections in some cases, the EMA says that they’re not feasible for investigator sites. In cases where remote GCP inspections are not feasible, the EMA guidance recommends that the inspection team notify the organization “without delay.” The EMA, Committee for Medicinal Products for Human Use and the site/sponsor can subsequently determine the most suitable next step of action, such as adjusting procedure timelines to support an on-site inspection when current pandemic-related restrictions are lifted.