Risk Based Monitoring is a common practice in the field of clinical trials. Opposed to standard clinical monitoring, Risk based monitoring is "the process of ensuring the quality of clinical trials by identifying, assessing, monitoring and mitigating the risks that could affect the quality or safety of a study." 2
The priority of traditional monitoring is to ensure patient safety and data quality, but utilizing RBM has glaring advantages in terms of efficiency and enhanced capability. To better understand the advantages to using RBM for a study let’s assess why a company should use this system to approach the planning process.
Assessing the risk associated with the study can serve as a foundational step for a risk based strategy. This assessment would include:
- Define data and the processes associated with patient safety and quality of data
- Implementing thresholds and indicators that warrant a site investigation and/or corrective measures
- Finding the risks associated with the study and coming up with processes to address them
CROs utilizing Risk Based Monitoring may want to consider engaging in prep action items. Assigning roles to your staff with operational instructions is a first step that allows effective use of your team. Creating a flow chart that features a decision tree as to what the team can do if a failure event occurs. For example, a failure event could involve standards and best practice violation or emergency audit. Finally, a premium importance must be placed on training your team from entry level to management on how RBM works. The Risk Based Monitoring strategy provides more flexibility to a study when caution and smart budgeting are placed into the scope of capabilities. A sponsor that is pursuing a study must approach the project with the caveat that no two clinical trials are the same, even within the same indication. To implement strategies, such as RBM, that provide flexibility to handle issues that arise allows that flexibility. Assessing risk before it occurs is an expedient step to a successful trial.
1. Risk-Based Monitoring. Clinical Leader. https://www.clinicalleader.com/doc/risk-based-monitoring-understanding-the-future-of-clinical-trial-monitoring-0001
2. Risk Based Monitoring in Clinical Trials. JMP. https://www.jmp.com/en_us/software/clinical-data-analysis-software/risk-based-monitoring.html