K

Key Risk Indicator (KRI): A specific measurement used to monitor and assess potential risks associated with the conduct of the trial. They provide early warning signs of potential issues or deviations that may impact participant safety, data integrity, or the overall success of the study.

Examples of KRIs can be AE report timeliness or query resolution time. The delays in both activities may be considered a sign of the study personnel's neglect. Thus, monitoring is required to ensure the proper conduction of trial activities.

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