High Percentage of Image interpretation issues (Quality)
| High Percentage of Image interpretation issues (Quality) (kri) |
|
| Type of indicator |
Risk |
| Risk Category |
data collection procedures |
| Golden KRI |
NO |
| Therapeutic Area |
General |
| IF Risk-Event |
images cannot be interpreted centrally |
| DUE TO Risk Causes |
poor image quality |
| THEN Risk Impact MAY RESULT |
the removal of many Subjects' data from the statistical analysis |
| Risk Indicator |
High Percentage of Image interpretation issues (Quality) |
| Metric |
Percent of low quality images |
| Unit |
% |
| What level should be measured |
Study, Country, Site, Subject |
| Comments |
|
| Purpose |
Optimize the accuracy and reliability of image interpretations, ensuring high-quality diagnoses and effective Subject management. |
| Description |
Monitors the occurrence of issues in the interpretation of medical images, ensuring accurate diagnoses and effective Subject care. |
| Formula |
Divide a number of images with low quality by Number of assessed images, multiply by 100. |
| Suggested Thresholds - High |
>10 % |
| Suggested Thresholds - Medium |
>5 % |
| Associated Metric 1 |
Number of enrolled Subjects |
| Associated Metric 2 |
Number of available images |
| Associated Metric 3 |
Number of available images with low quality |
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