The Periodic Monitoring Visit
This course provides an in depth review of all activities related to the monitoring of a clinical investigation after initiation including:
- How to prepare for the visit,
- How to plan and confirm the visit,
- How to handle deviations including several case studies,
- How to handle personnel changes or changes in resources including case studies,
- Ensuring accurate reporting of data including safety data,
- How to report any findings during the visit and follow up on actions required by the site personnel.
Watch the Course Trailer:
Upon completion of this course, trainees will be able to correctly and successfully:
- Plan effectively a periodic monitoring visit, setup an accurate agenda and ensure efficiency during the visit,
- Detect and handle non-compliances from the site personnel,
- Ensure appropriate reporting from the site to Ethics Committees or Institutional Review Boards and where needed to regulatory authorities,
- Develop a system for organizingmonitoring visits including effective logistics and time management,
- Develop a system for accurate follow up after a monitoring visit and ensure compliance of the site personnel.
Monitors / Clinical research associates, clinical trial assistants, clinical trial coordinators.
Understand the basis of Good Clinical Practice (ID 42), what is a clinical investigation plan (ID 44) ,an informed consent process (ID 45) and adverse event processes (ID 59) is needed to have a meaningful understanding of this course. This course should be taken in combination with the course on source document verification (ID 52), device accountability (ID 50), deviations and non-compliance handling (ID 51) and the case report form process (ID 53).