High Percentage of Subject Death


High Percentage of Subject Death Table

High Percentage of Subject Death

Type of indicator Risk
Risk Category Safety
Golden KRI No
Therapeutic Area General
IF Risk-Event Subject deaths occur
DUE TO Risk Causes Surgery or other reasons
THEN Risk Impact MAY RESULT A study hold or study termination
Risk Indicator High Percentage of Subject Death
Metric Percent of Subjects Died
Unit %
What level should be measured Study, Country, Site
Purpose 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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