The Periodic Monitoring Visit

This course provides an in-depth review of the activities related to monitoring clinical investigations after initiation. The course includes numerous practical examples based on real-life situations that monitors can encounter during ongoing monitoring activities of medical device clinical investigations.

It covers the following topics:

• Preparing for visits whether onsite or remote
• Planning and confirming visits
• Case studies of handling deviations, personnel changes, or changes in resources
• Ensuring accurate reporting of data, including safety data
• Reporting findings during visits 
• Following up on actions required by site personnel