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 |
Incorrect tumor grading or incorrect assessment of the investigational medicinal product (IMP) |
| THEN Risk Impact May Result |
Undue risk to subject safety and well-being, potentially leading to study hold or termination |
| Risk Indicator |
High percentage of early subject deaths |
| Metric |
Percentage of subjects with a survival period shorter than expected |
| Unit |
% |
| Measurement Level |
Study, Country, Site |
| Purpose |
Ensure subject safety and ethical conduct of clinical trials through early identification of undue risk to subject safety. |
| Description |
This KRI monitors the proportion of early deaths among study subjects and triggers an alert if the proportion exceeds expected levels. |
| Formula |
(Number of subjects who died within XXX months ÷ number of enrolled subjects who reached XXX months in the study) × 100 |
| Suggested Threshold – High |
> 5% |
| Suggested Threshold – Medium |
> 3% |
| Associated Metric 1 |
Number of enrolled subjects |
| Associated Metric 2 |
Number of days in the study |
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