Overrecruitment (kri)
Type of indicator Performance
Risk Category subject population
Golden KRI NO
Therapeutic Area General
IF Risk-Event a Site/Country/Study recruits more Subjects than statistically planned
DUE TO Risk Causes a lack of control over the IXRS and the screening
THEN Risk Impact MAY RESULT an unusual statistical analysis and difficulties in the interpretation
Risk Indicator Overrecruitment
Metric Percent of Overrecruited Subjects
Unit %
What level should be measured Study,Country,Site
Purpose Maintain the integrity of clinical trials or research studies by ensuring that the number of enrolled participants aligns with planned targets and ethical considerations.
Description KRI monitors instances where the number of participants enrolled in a clinical trial or research study exceeds the predetermined target, ensuring adherence to enrollment plans and mitigating potential risks to participant safety and data quality.
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 >120 %
Suggested Thresholds - Medium >110 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of planned Subjects
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