High Percentage of Screen Failures

High Percentage of Screen Failures (kri)
Type of indicator Performance
Risk Category subject population
Golden KRI YES
Therapeutic Area General
IF Risk-Event high screen failure rate
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT a study duration impact
Risk Indicator High Percentage of Screen Failures
Metric Percent of screen Failures
Unit %
What level should be measured Study,Country,Site
Purpose To detect whether there may be site issues with screening. For example, site selecting many potential participants who are ineligible, or site not applying the screening process/criteria correctly. At study level, it can detect the risk of the screen failure rate being higher than expected and, therefore, the risk of extended enrollment timelines.
Description KRI monitors the risk of a high level of screen failures at the site. It alarms if the percentage of screen failures out of all those who have completed screening is high relative to other sites or in the study in general.
Formula Devide the number of screening failures by the total number of screened Subjects (independent of enrollment).
Suggested Thresholds - High >20 %
Suggested Thresholds - Medium >10 %
Associated Metric 1 Number of screening Failures
Associated Metric 2 Number of screened Subjects
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