Ensure participant safety and the ethical conduct of clinical trials or healthcare settings by identifying and addressing potential risks leading to subject deaths.
Description
KRI monitors the occurrence of a significant proportion of deaths among study participants in clinical trials or healthcare settings, highlighting the need for enhanced participant safety measures, timely interventions, and investigations into the causes of mortality.
Formula
Divide the number of randomized Subjects Died by the number of randomized Subjects, multiply by 100%.
Suggested Thresholds - High
>0.1 %
Suggested Thresholds - Medium
>0.05 %
Associated Metric 1
Number of randomized Subjects
Associated Metric 2
Number of randomized Subjects Died
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