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.
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).