Monitoring Investigator-Initiated Trials

About the Course

This interactive two-day training provides in-depth knowledge on monitoring investigator-initiated studies in clinical trials. Regulations require the sponsor to ensure quality control of the study by an independent monitor, even when the investigator is also the sponsor. The course covers every step, from preparation to closeout. The course is given in Swedish (Monitorering av prövarinitierade studier).

Who Should Attend

The course is primarily intended for research nurses and research support staff who are currently working with, or are about to begin working with, the monitoring of investigator-initiated studies

Learning Objectives

The course covers the monitoring of clinical trials in which the investigator is the sponsor. You will gain knowledge on how, as a monitor, to prepare, initiate, oversee, and close a study, equipping you to apply this knowledge in an investigator-initiated study.

Course Content

The course structure is interactive and relies on active participation from the attendees. During the course, participants will work from a protocol and systematically go through the various steps involved in monitoring an investigator-initiated study.

• What is quality control/monitoring of clinical trials?
• Monitoring of investigator-initiated studies
• Preparing for a monitoring project: What do I need to know before saying yes?
• Study initiation
• Monitoring visit
• Monitoring report
• Closeout visit
• Inspection of investigator-initiated studies