The Fundamentals Of Monitoring and Coordinating in Clinical Research. A CRA Academy Highlight Reel

Monitors must be able to recognize any site errors they see during their onsite visits. Whether there is a protocol deviation, consistent data reconciliation errors, or errors in the ICF, monitors should be able to note such problems in their reports and create action items as needed. Monitor reports are typically written by the monitor then reviewed by a supervisor and eventually reviewed by the sponsor in order to ensure quality.