Safety Oversight, Monitoring and Reporting

Familiarise yourself with the what, when and how of safety oversight, monitoring and reporting in clinical trials of medicines and devices across the trial lifecycle.

Learn who is responsible for managing safety oversight, monitoring and reporting at both the Sponsor-level and site-level and resources developed by CRDO to support these activities.

We will cover applicable regulations and guidelines and how these apply to different roles – Sponsor-Investigator, Site PI, Human Research Ethics Committee, local Research Governance Office and the Therapeutic Goods Administration (TGA). 

Risk assessment and management will be explored with a focus on participant safety and include how to identify and control risks related to participant safety and how to use this assessment to develop a risk-based approach to monitoring and reporting on participant safety.

We will also discuss role of Data Safety Monitoring Boards in safety oversight and when a trial may need one.

We will then discuss how to monitor and report safety events to relevant stakeholders and share some useful resources.

This workshop is a pre-requisite for the CRDO workshop Monitoring Investigator-Initiated Clinical Trials. 

Target audience: This course is suitable for research staff involved in investigator-initiated trials at either a Sponsor-level or site-level, or in an externally sponsored trial at a site level.

Available only for campus staff & students: For externals, contact [email protected] to discuss if this course is suitable for you and if there is a vacancy. 

Pre-requisites: Completion of a TransCelerate-recognised GCP course within the last three years. Please contact CRDO if you would like to discuss further.