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
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 Devide a number of images with low quality by Number of available images, multipy 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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