The Periodic Monitoring Visit
Course Description:
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
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Plan an effective periodic monitoring visit whether remote or onsite
- Use remote monitoring tools in addition to onsite visits.
- Set up a logical agenda and ensure efficiency during the visit
- Detect and handle non-compliance from site personnel
- Ensure appropriate reporting from the site to ethics committees, institutional review boards, or regulatory authorities when necessary
- Create a system for organizing monitoring visits, including logistics and time management
- Develop a system for accurate follow-up after monitoring visits and ensure compliance of site personnel
Who Should Enroll:
Monitors, clinical research associates, and clinical trial assistants and coordinators are all welcome to enroll in this course.
Prerequisite Knowledge/Requirements:
The following courses are required:
- Introduction to Good Clinical Practice (ID 42)
- The Clinical Investigation Plan (ID 44)
- The Informed Consent Process (ID 45)
- Adverse Event Processes (ID 59)
- Device Accountability (ID 50)
- Deviations and Non-Compliance Handling (ID 51)
- Source Document Verification (ID 52)
- The Case Report Form Process (ID 53)