Underrecruitment

Underrecruitment
Type of indicator Performance
Risk Category Subject Population
Golden KRI YES
Therapeutic Area General
IF Risk-Event Enrollment is significantly lower than planned
DUE TO Risk Causes Difficulties in finding subjects who meet the inclusion/exclusion criteria
THEN Risk Impact MAY RESULT Low study power, inability to determine efficacy and/or safety, or study delays leading to increased costs due to protocol amendments or additional site start-ups.
Risk Indicator Underrecruitment
Metric Percent of Subjects Enrolled Versus Planned
Unit %
What level should be measured Study, Country, Site
Purpose Detect whether enrollment is on track and assess the likelihood of achieving full recruitment and meeting study timelines.
Description This KRI monitors the enrollment rate. It triggers an alert if recruitment performance is significantly below expectations.
Formula (Number of Subjects Enrolled) / (Planned Number of Subjects Enrolled) × 100. Use values from the same date.
Suggested Thresholds - High 80%
Suggested Thresholds - Medium 90%
Associated Metric 1 Number of Subjects Enrolled
Associated Metric 2 Planned Number of Subjects Enrolled
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