Guidance from the US FDA outlines steps in a risk-based approach to 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 clinical study.
We can accurately monitor the quality of a study and the safety of its Participants. A sponsor must know which elements are most important for each particular study – from informed consent to eligibility screening and tracking of serious adverse events.
Perform a risk assessment that involves determining specific sources of risk and the effect of study errors on those risks. According to FDA's guidance, a monitoring plan should "describe the monitoring methods, responsibilities, and requirements of the trial." The plan is responsible for communicating the risks and monitoring procedures to everyone involved in monitoring the clincal trial.
Compared to earlier clinical trial monitoring methods, like 100% source data verification (“SDV”), RBM can lead to increases in quality data, patient safety and the overall efficiency of a clinical study. Specifically, it can enable:
