Clinical Research and GCP Update

47

Some Features of a recent UK Remote GCP Inspection, during COVID-19 pandemic

• Either remote access to e-SOP system or (if remote access is not a feature), electronic copies of SOPs supplied. • Using e-Repositories for document provision. • Inspectors review e-TMF on their own ̶ and only contact Host if any questions. • Use of WebEx or MS Teams to interview. • Be prepared to provide information on COVID -19 mitigation measures.

47

48

© Brookwood Global (Canary Ltd) 2021

24