In the context of this guidance, a remote / distant GCP inspection is defined as “the process of conducting inspections at a distance / virtually, supported by technology for communicating, sharing, reviewing, and developing documents and accessing systems, without the inspectors being physically present at the sites where the activities subject to an inspection have taken place / where the inspection would routinely be hosted”.
Sponsors, CROs and service providers (e.g. medical imaging, central laboratories) in general, often have at their disposal advanced technologies, electronic systems and virtual working environments which facilitate remote staff or company locations worldwide to communicate systematically. These technologies may allow the necessary access for inspectors to the relevant systems (e.g. electronic trial master file (eTMF)) remotely and enable appropriate communication settings during inspection.
Guidance on remote GCP inspections during the COVID19 pandemic