High Percentage of Subject Death


High Percentage of Subject Death Table
Type of indicator Risk
Risk Category Safety
Golden KRI No
Therapeutic Area General
IF Risk-Event Subject deaths occur during the study
DUE TO Risk Causes Surgical complications, disease progression, investigational product effects, or other medical causes
THEN Risk Impact MAY RESULT Potential study hold or termination, as well as ethical and regulatory implications requiring immediate investigation and action
Risk Indicator High Percentage of Subject Death
Metric Percentage of Subjects Who Died
Unit %
What level should be measured Study, Country, Site
Purpose This KRI ensures continuous oversight of participant safety and ethical trial conduct by identifying any elevated rate of subject deaths, enabling prompt corrective actions and safety reviews.
Description This KRI tracks the proportion of deaths among randomized study participants. An unexpected increase may indicate underlying safety risks associated with the investigational product, procedures, or study design, warranting investigation and risk mitigation.
Formula (Number of Randomized Subjects Who Died ÷ Total Number of Randomized Subjects) × 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 Who Died
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