Project monitoring

The Barwon Health Research Safety Monitoring, Reporting and Management Procedure can be viewed by clicking here. This advice is provided to researchers to clarify the role of all research stakeholders in addressing the monitoring, collection and reporting of adverse events and serious breaches that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs). Please refer to this document for guidance and submission requirements for safety events and/or safety items at Barwon Health

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.