Subjects miss too many visits (whether in clinic or home healthcare)
DUE TO Risk Causes
Their health condition or disengagement
THEN Risk Impact MAY RESULT
Missing assessments and critical data leading to difficulty in evaluating the investigational product
Risk Indicator
High percentage of missing visits
Metric
Percent of missing visits
Unit
%
What level should be measured
Study, Country, Site, Subject
Comments
As this is a measurement against expected visits, unscheduled visits are not included in the calculation.
Purpose
To monitor the loss of data through missing visits (if the visit data does not exist because a visit did not occur that is a more significant issue than data not finding its way into the eCRF). By tracking and analyzing this key risk indicator, organizations can identify potential gaps in data, adherence to protocols, and/or participant engagement.
Description
The KRI controls exceeding the number of a subject's missed visits in line with the study protocol. It alarms if the calculated percent is too high.
Formula
(Number of Planned Visits - Number of Completed Visits) / (Number of Planned Visits) x 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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