High Percentage of Image interpretation issues (Quality)

High Percentage of Image Interpretation Issues (Quality) Table
Type of indicator Risk
Risk Category Data Collection Procedures
Golden KRI No
Therapeutic Area Oncology
IF Risk-Event Images cannot be interpreted centrally.
DUE TO Risk Causes Poor image quality or incorrect image acquisition procedures.
THEN Risk Impact MAY RESULT Removal of a substantial number of subjects’ data from statistical analysis, affecting data completeness and study validity.
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 May require access to central imaging quality control data for assessment.
Purpose Ensure the reliability and accuracy of image data by monitoring the proportion of images that are of insufficient quality for central review or analysis.
Description This KRI monitors the rate of low-quality medical images that cannot be interpreted centrally, identifying potential site-level or equipment-related quality issues.
Formula The number of images with low quality/The total number of assessed images X 100
Suggested Thresholds - High 10%
Suggested Thresholds - Medium 5%
Associated Metric 1 Number of Assessed Images
Associated Metric 2 Number of Images with Low Quality
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