Subjects miss too many scheduled visits (either on-site or via home healthcare)
DUE TO Risk Causes
Health condition, lack of engagement, or logistical barriers
THEN Risk Impact MAY RESULT
Missing assessments and critical data, leading to difficulties in evaluating the investigational product and ensuring study validity
Risk Indicator
High Percentage of Missing Visits
Metric
Percent of Missing Visits
Unit
%
What level should be measured
Study, Country, Site, Subject
Comments
Unscheduled visits are excluded from the calculation.
Purpose
Monitor data loss due to missed visits, which directly impacts study completeness and quality. Tracking this KRI supports proactive management of protocol adherence and subject engagement to minimize missing data and ensure study integrity.
Description
This KRI monitors the percentage of scheduled visits missed by subjects according to the study protocol. It triggers an alert when the rate of missed visits exceeds acceptable limits.
Formula
(Number of Planned Visits − Number of Completed Visits) / (Number of Planned Visits) × 100. Use values from the same date.
Suggested Thresholds - High
10%
Suggested Thresholds - Medium
5%
Associated Metric 1
Number of Completed Visits
Associated Metric 2
Number of Planned Visits
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