Risk Management

The TGA: ICH Guideline for Good Clinical Practice states that the Sponsor, and Sponsor-Investigator in the case of an investigator-initiated trial, is responsible for managing quality throughout all stages of the clinical trial. The 2016 update to the guideline emphasises the importance of a risk-based approach to quality management. One element of this is risk management where resources are focused on reducing and managing significant risks to participants, including rights, well-being and safety, as well as the reliability of the trial results.  

What is risk management?

It is a proactive approach to preventing potential issues with the aim of avoiding unwanted outcomes and involves the following components:

1. Risk identification
2. Risk assessment
3. Risk mitigation
4. Risk monitoring and review
5. Communication and consultation

Download the risk overview

Managing risks during the clinical trial life cycle

Risks may be identified at different stages of the clinical trial life cycle. Additional information and resources may be used by researchers to apply a risk management approach during the planning and trial conduct stages as follows:

• Protocol development, see Trial Risk Assessment and Management
• Sponsorship (by host institution) application process, see Sponsorship Risk Assessment and Management
• Monitoring Trial Conduct
• Safety monitoring and reporting, see Safety Monitoring and Safety Reporting

These risks may be new or they may be existing but with a change over the course of the trial in the likelihood of the risk occurring or the impact that the risk has on participant safety or the trial results.

Guidelines

• TGA: ICH Guideline for Good Clinical Practice
• Suprin, M et al. Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development, Therapeutic Innovation & Regulatory Science 2019, Vol. 53(1) 36-44
• US FDA: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers