Overrecruitment

Overrecruitment Table
Type of indicator Performance
Risk category Subject population
Golden KRI NO
Therapeutic area General
IF risk event A site, country, or study recruits more subjects than statistically or operationally planned
DUE TO risk causes Lack of recruitment control through IXRS, delayed enrollment cut-off communication, or oversight in screening limits
THEN risk impact may result Increased study costs, ethical concerns, and complications in statistical analysis or data interpretation
Risk indicator Overrecruitment
Metric Percentage of overrecruited subjects
Unit %
What level should be measured Study, country, site
Purpose Ensure adherence to planned enrollment targets to maintain ethical standards, control study costs, and prevent deviations from statistical assumptions or safety oversight.
Description This KRI tracks when actual recruitment exceeds planned levels, helping to identify lapses in enrollment control mechanisms and prevent unnecessary exposure of additional participants.
Formula (Number of enrolled subjects ÷ Planned number of subjects for the same date) × 100%
Suggested thresholds - high 120%
Suggested thresholds - medium 110%
Associated metric 1 Number of enrolled subjects
Associated metric 2 Number of planned subjects
Do you like the KRI description? Thanks for the feedback There was a problem submitting your feedback. Please try again later.