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Risk-based monitoring (RBM)

Risk-Based Monitoring (RBM) refers to a monitoring approach that outlines the identification, assessment, and mitigation of risks associated with the performance of clinical trials. Risk assessment implies the identification of potential hazards and issues associated with the trial, including protocol deviations, data discrepancies, and adverse events. Risk mitigation entails the development of a plan to manage and reduce the identified risks. This may involve targeted monitoring activities such as remote monitoring, centralized monitoring, or on-site monitoring.

The following tools help in systematically managing risks throughout the clinical trial process:

  • Risk assessment and categorization tool (RACT): helps in identifying and categorizing risks based on severity, likelihood, and impact, allowing for better prioritization of monitoring activities.

  • Key risk indicator (KRI): defines specific metrics that help in detecting and assessing potential risks in clinical trials, enabling proactive risk management.

  • Risk tracking: provides a structured way to monitor identified risks, track their status, and document actions taken to address them throughout the trial.

  • Autoexecution engine: automates predefined risk-based monitoring tasks, reducing manual effort, and ensuring that mitigation steps are executed efficiently.

  • Mitigation actions: enables users to implement and track corrective or preventive measures to address identified risks, ensuring that appropriate actions are taken in a timely manner.

In this section:

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

CRAs