What is a Key Risk Indicator (KRI)

Controlling risks is the process of overseeing risks to timely identify and prevent foreseeable and new risks, control risk occurrence, and validate risk response efficacy during the study conduct phase.

Risk monitoring and control are not a novelty in clinical trials. However, risk control was lacking a systematized procedure for a sound deployment in clinical research.

In order to apply a systematic approach for risk-based quality management, clinical trials rely nowadays on the so-called risk indicators. A risk indicator could be defined as a metric used to measure a specific risk, with its relevant control limits (thresholds) and alerts. These alerts are signals sent to the risk owner and relevant team members that are triggered when a pre-defined risk level or threshold has been reached. Sometimes identified risks are not clearly linked to the risk indicators used by the monitor and that relationship should have been established already in the clinical study planning phase.

Each risk must be measurable, via a KRI, and have clearly defined risk tolerance or control limits, as reference thresholds. Once a KRI is close to reaching a threshold, an alert should be triggered, and that should happen timely for the effective prevention of threats. Additionally, the timelines for regular risk monitoring and reporting should be clarified

The type of alerts, IT systems, and the communication method (i.e., phone calls, automated e-mail notifications, online platforms, etc.) should be well-known. Likewise, the clinical study team must have available a description of actions and procedures to follow (i.e., root cause analysis, investigation of serious issues, or CAPA).