A Pilot Study into the Impact of Remote Monitoring on the Trial Site

Abstract

Remote monitoring as the primary method of clinical trial oversight is increasingly common due to advancements in technology which allow SDV to be performed without site visits. However, remote monitoring often changes the workflow of the clinical trial site staff. This study aims to determine how remote monitoring affects the time allocation of site staff toward duties related to monitoring visits, and to identify which tasks are most affected when the sponsor uses a remote monitoring strategy. A survey was sent out to clinical research staff within BSWRI. Research staff tended to spend less time toward remote monitoring duties than on-site monitoring duties. Submitting source documents, regulatory, and AE documentation were identified as more time-consuming for remote monitoring, while preparing for visits and assisting the monitor while on-site were identified as more time-consuming for on-site monitoring. This study identified potential targets for improvements in the workflow of clinical trial sites.