Underrecruitment

Underrecruitment (kri)
Type of indicator Performance
Risk Category subject population
Golden KRI YES
Therapeutic Area General
IF Risk-Event only a few endpoint data can be acquired
DUE TO Risk Causes underrecruitment
THEN Risk Impact MAY RESULT a low study power, a delay in study completion or a protocol amendment
Risk Indicator Underrecruitment
Metric Percent of Underrecruitment Subjects
Unit %
What level should be measured Study/Country/Site
Purpose To detect whether the enrollment is such that the planned number of Subjects may not be reached till the scheduled deadline (or at all) and thus the study may be delayed.
Description This KRI monitors the risk of the enrollment rate being lower than planned.
Formula Devide an actual number of enrolled Subjects by a planned number of Subject for the same date and multiply by 100%.
Suggested Thresholds - High <80 %
Suggested Thresholds - Medium <90 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of planned Subjects
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