In a recent blog post, we provided an overview of the “Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” that the FDA released this past August. Risk-based monitoring continues to remain a hot topic as the industry navigates its comfort level with this new approach.
Many people are under the impression that risk-based monitoring equates to less monitoring, which isn’t actually the case. IMARC Research has utilized risk-based monitoring since the company was founded and we have always believed that Risk-Based Monitoring =Informed Monitoring. In fact, if you step back and consider how you manage a clinical trial, you will probably notice that you have been employing some level of risk-based methods yourself. Maybe you have worked with one particular site many times before and you know you can count on them to deliver quality care to research the subject while collecting accurate data. Perhaps knowing this, you choose to postpone their monitoring visits until after site visits to newer, less experienced sites can be made. This is risk-based monitoring!
Every trial, and even different sites within a trial, may require a different monitoring approach. When it comes to employing a risk-based approach, one should always first consider the level of risk involved when making an informed decision about study management. A thoughtful analysis about these things on the front end should inform what types of monitoring activity can be performed remotely, and what will still require an on-site visit. We previously released a whitepaper on the topic, and have now put together a checklist based on the FDA’s guidance that can be used to help guide this decision-making process.
Please download IMARC’s Risk-Based Monitoring Checklist and share your thoughts below.