A high proportion of data points have not been entered into the eCRF
DUE TO Risk Causes
System challenges, site workload, or delays in data entry processes
THEN Risk Impact MAY RESULT
Inability to monitor data in a timely manner, delayed detection of critical issues, and potential delays in database lock or study completion.
Risk Indicator
High Percentage of Missing eCRF Entries
Metric
Percent of Missing eCRF Entries
Unit
%
What level should be measured
Study, Country, Site
Comment
Unscheduled visits, (S)AEs, medical history, and concomitant medication fields are excluded from the calculation.
Purpose
Ensure timely and complete data entry by sites to enable central monitoring, maintain data quality, and prevent delays in issue detection or study timelines. This KRI highlights missing data but does not differentiate between unavailable and unentered data, requiring follow-up to confirm the cause.
Description
This KRI monitors the proportion of missing eCRF data. It triggers an alert when the percentage of unentered mandatory fields exceeds expected thresholds.
Formula
(Number of Empty eCRF Fields) / (Number of Empty eCRF Fields + Number of Complete eCRF Fields) × 100. Include only mandatory fields across all forms, as defined in the metadata specification.
Suggested Thresholds - High
20%
Suggested Thresholds - Medium
10%
Associated Metric 1
Number of Empty eCRF Fields (Mandatory)
Associated Metric 2
Number of Complete eCRF Fields (Mandatory)
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