Quality Risk Management In Clinical Trials

This lesson describes what the main process steps a basic Quality Risk Management (QRM) should contain. It also reviews some of the key terms used in a QRM process, and the personnel that should be involved.

Before setting out to identify and mitigate the risks it is first necessary to establish a multidisciplinary risk assessment team comprised of experts from the appropriate areas (for example: quality assurance, clinical operations, clinical informatics, IT), in addition to individuals who are knowledgeable about the QRM process.

Before setting out to identify and mitigate risks it is first necessary to establish the priorities. Since we cannot focus on everything, it is key to prioritize by focusing on critical processes and data.

This lesson explains how to establish the priorities. It provides guidance on how to initiate and plan the QRM process. It also tells how to formulate the risk question which is the starting point of the QRM exercise.

Risk assessment is the overall process of risk identification, risk analysis and risk evaluation.

This lesson breaks down the risk assessment process, specifying how each phase should be conducted, listing what type of risk assessment methods can be applied, and explaining how the output of the risk assessment can be documented.

Once the risks have been identified and analysed, the next step is to develop appropriate risk response strategies.

During this lesson, we explain how risks can be mitigated by avoiding them, reducing them to an acceptable level or accepting them as they are. The lessons covers mitigation strategies, and clarifies the main differences between Key Risk Indicators (KRI) and Quality Tolerance Limits (QTL).

This lesson also describes the content that a Risk Management Plan (RMP) should contain.

Throughout the entire risk management process, steps for risk communication and documentation of activities have to be incorporated. The method of risk communication will vary depending on the organization.

This lesson highlights the relevance of the risk communication strategy to assist the key stakeholders in understanding the risks, the basis on which decisions are made and the reason why particular actions are required.

This lesson guides you through the communication planning, which includes the identification of the important stakeholders of quality risk management processes, the development of a communication plan, and the execution of that communication plan.

The Monitoring and review step involves the review of risks, mitigation actions, and subsequent results; this step examines whether or not the identified risk was controlled appropriately and the result.

This step may also result in new risks being identified, and these risks would need to be managed.

Risk reporting as per ICH E6(R2) is specific to reporting quality performance at the trial level.

This lesson covers the ICH GCP risk reporting requirements, explaining how to comply with them.