【PURPOSE】
The purpose of this Standard Operating Procedure (SOP) is to describe the processes for conducting and managing monitoring activities throughout the study, and closing, cancelling, or terminating each site.
【SCOPE】
This SOP applies to clinical studies contracted with sponsor to conduct site management and monitoring. If sponsor’s specific procedure is required for site management and monitoring, it must be specified in contract/work order or other document which SOPs will be followed for certain activities.
Site management and monitoring starts when a site is selected for initiation and ends when the site is closed.