All protocol deviations should be recorded in the study site master file.

HREC only requires protocol deviations deviations that affect patient safety or ethical considerations of the project or significant disruption to the project.

If a deviation or violation is being reported, please submit via email to research@monashhealth.org using the Department of Health and Human Services template available at: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting