High Percentage of Early Subject Deaths

High Percentage of Early Subject Deaths (kri)
Type of indicator Risk
Risk Category safety
Golden KRI NO
Therapeutic Area Oncology
IF Risk-Event Subjects die earlier than anticipated
DUE TO Risk Causes incorrectly assessed tumor grading
THEN Risk Impact MAY RESULT a study hold or study termination
Risk Indicator High Percentage of Early Subject Deaths
Metric Percent of Subjects with survival period less than Expected Survival period
Unit %
What level should be measured Study, Country, Site
Purpose Ensure participant safety and the ethical conduct of clinical trials or research studies by identifying and addressing potential risks leading to early Subject deaths.
Description KRI monitors the occurrence of a significant proportion of deaths among study participants at an early stage in clinical trials or research studies, highlighting the need for enhanced participant safety measures and timely intervention to prevent untimely mortality.
Formula Calulate number of enrolled Subjects who died less than in XXX months, devide by a total number of Subjects, multiply by 100%.
Suggested Thresholds - High >70 %
Suggested Thresholds - Medium >50 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of Days in the Study
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