Difficulties in finding patients that meet the inclusion/exclusion criteria
THEN Risk Impact MAY RESULT
A low study power which is unable to determine efficacy and/or safety or a delay in the study and increased cost through protocol amendment and/or additional site start-up.
Risk Indicator
Under enrollment
Metric
Percent of subjects enrolled versus planned
Unit
%
What level should be measured
Study, Country, Site
Purpose
To detect whether enrollment is to plan and indicate whether it is likely the plan for full enrollment, and therefore study timelines, will be met.
Description
This KRI monitors the enrollment rate. It alarms if it is significantly lower than expected.
Formula
(Number of Subjects Enrolled)/(Planned Number of Subjects Enrolled)x100. 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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