High Percentage of Early Subject Deaths

High Percentage of Early Subject Deaths Table

High Percentage of Early Subject Deaths

Type of indicator Risk
Risk Category Safety
Golden KRI No
Therapeutic Area Oncology
IF Risk-Event A higher than expected proportion of subjects die early
DUE TO Risk Causes Incorrectly assessed tumor grading or IMP
THEN Risk Impact MAY RESULT Undue risk to safety and well-being of trial participants and hold or termination of the study
Risk Indicator High Percentage of Early Subject Deaths
Metric Percent of subjects with survival period less than expected
Unit %
What level should be measured Study, Country, Site
Purpose Ensure participant safety and the ethical conduct of clinical trials or research studies by early identification of undue risk to subject safety.
Description This KRI monitors the proportion of early deaths among study participants. It alarms if the proportion is higher than expected.
Formula Calculate number of enrolled Subjects who died within XXX months, divide by the total number of enrolled Subjects who passed XXX months in the Study, 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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