A Risk-based Monitoring Plan will also allow for additional monitoring to occur at a site on a case-by-case basis and as needs arise. For example, if a CRA takes note of protocol deviations or there are concerns related to subject safety and/or data validity, the CRA may deviate from the Risk-based Monitoring Plan to monitor additional data than that which is required per the plan.
The FDA has provided guidance on risk –based monitoring within a guidance document titled “Oversight of Clinical Investigations-A Risk-based Approach to Monitoring”. The guidance outlines the rationale for Risk-based monitoring, as well as monitoring approaches, proper management of non-compliance, and appropriate communication and documentation of monitoring activities. This guidance document can be reviewed by clicking on the link below:
Overall, a Risk-based Monitoring Plan allows sponsors and Clinical Research Organizations (CROs) to be more efficient in their monitoring activities, monitoring critical data points and appropriately reviewing subject safety and protocol compliance while utilizing fewer resources in doing so. The key to a successful risk-based monitoring program is proper assessment of study risks and critical data points prior to study start, adequate CRA training, and continued management and oversight of clinical research sites throughout the life of the trial.