RISK-BASED MONITORING

August 19 2015 Kara Grew
Risk-based monitoring in clinical trials involves targeted monitoring that may include 100% source data verification for specified critical data points and partial source data verification of other data. In most cases, the risks of the trial and the data to be collected are determined prior to study and site initiation, to identify monitoring needs. In addition, a Medical Monitor or Clinical Director will often provide input into the identification of critical data points based on the therapeutic area, indication, overall protocol requirements, safety profile of the compound, device or biologic,  and the primary and secondary endpoints for evaluation. Once the plan for targeted monitoring is finalized by the study team, the Risk-based Monitoring Plan will be included as part of the overall Monitoring Plan and Clinical Research Associates (CRAs) assigned to the trial will be trained on these monitoring requirements.
 

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:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm269919.pdf

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.