Risk Assessment and Management Plan
Guidance to assist the Sponsor-Investigator or delegate to conduct a risk assessment for their trial and develop a plan to manage the risks from trial design through to reporting results.
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.
It is a proactive approach to preventing potential issues with the aim of avoiding unwanted outcomes and involves the following components:
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:
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.