Project monitoring

Please click here to view the Barwon Health Guidelines for Research Safety Monitoring and Reporting (updated September 2021).

A safety report is required for the following;

• Any event that may impact the safety, dignity, or welfare of participants AND/OR the integrity of project data
• Protocol breaches (suspected, non-serious and serious)

To prepare and submit a safety report, select the appropriate report from the drop down menu in Ethics Review Manager (ERM). 

A Riskman may also be required – please see ‘How to Enter a Clinical Trial Incident on Riskman’ guide for assistance with entering a Riskman related to a Clinical Trial. It may also be useful for entering non-trial Research Incidents.