High Percentage of Missing Forms (Pages)


High Percentage of Missing Forms (Pages)
Type of indicator Performance
Risk Category Data Collection Procedures
Golden KRI NO
Therapeutic Area General
IF Risk-Event A high number of eCRF forms (pages) have not been entered during a visit
DUE TO Risk Causes Site workload, lack of oversight, or insufficient data entry discipline
THEN Risk Impact MAY RESULT Delays in data review and database lock, impacting study timelines
Risk Indicator High Percentage of Missing Forms (Pages)
Metric Percent of Missing Forms (Pages)
Unit %
What level should be measured Study, Country, Site
Comments Only scheduled visits are included.
Purpose Ensure completeness of eCRF data by monitoring missing forms (pages) proactively to prevent delays in study progress and data integrity risks.
Description This KRI tracks the percentage of missing eCRF forms (pages) across visits. It triggers an alert if the rate of missing forms exceeds the acceptable limit, allowing for timely corrective actions.
Formula (Number of Empty Forms/Pages) / (Total Number of Expected Forms/Pages) × 100.
Suggested Thresholds - High 20%
Suggested Thresholds - Medium 10%
Associated Metric 1 Number of Expected Forms (Pages) per Visit
Associated Metric 2 Number of Actual CRF Forms (Pages) per Visit
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