The traditional Gold Standard method of monitoring clinical trials involved on-site monitoring with 100% Source Data Verification (SDV) where Clinical Research Associates checked every data point of information reported. This may have been doable in the past when there were sufficient resources available to carry out 100% of every task needed. It not only involved a high resource demand and cost but also showed a negligible effect on data quality[1].
The U.S Food and Drug Administration (FDA), European Medicines Association (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA) recommend a Risk-Based Monitoring (RBM) as a means of delivering a more efficient way of clinical trial monitoring. RBM identifies that there is no single approach appropriate for every trial and encourages tailoring the monitoring plans to suit the needs of the trial involved. This may therefore involve a reduced SDV, Targeted Monitoring and/or Triggered monitoring. Deciding the level of monitoring needed for the trial is dependent on the Risk Assessment to be carried out at the beginning of the study. (A principle widely used across various sectors in identifying possible areas of concern within the business!) The initial Risk Assessment helps identify and understand the source and cause of risks that could occur either during data collection or performance of processes. Risks to be considered may include operational, regulatory, scientific or medical risks. Assessing these will help create a monitoring plan and a RBM strategy which shows regulators that a robust process exists in identifying risks and possible actions needed to manage those risks. The importance of documenting the monitoring plan after assessing these risks has been highlighted within the FDA guidance.
The purpose of RBM is to allow monitors to focus on ‘preventing quality issues from occurring than on only fixing problems’!
[1] Ben McGraw, ‘Speeding the Switch to Risk-Based Monitoring’, Informatics eNews for Translational and Clinical Development, 2015