Not possible to enroll the required number of participants, longer study duration or additional sites and cost.
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
This KRI monitors the risk of screen failures. It alarms if the percentage of screen failures is higher than expected.
Formula
(Number of Screen Failures)/(Number of Screened Patients)x100. Use values from the same date and do not include patients who have started but not yet completed screening.
Suggested Thresholds - High
>20 %
Suggested Thresholds - Medium
>10 %
Associated Metric 1
Number of Screen Failures
Associated Metric 2
Number of Screened Subjects
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