High Percentage of Missing Forms (Pages)

High Percentage of Missing Forms (Pages) (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI NO
Therapeutic Area General
IF Risk-Event a high number of forms have not been entered during a visit (visit report)
DUE TO Risk Causes sloppiness or workload at the Sites
THEN Risk Impact MAY RESULT a delayed database closure
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
Purpose The purpose of this KRI is to proactively manage the risk of data inaccuracies, ensure data quality, and support informed decision-making based on complete and reliable information.
Description The KRI controls exceeding percent of missing Forms (Pages). It alarms if the calculated percent is too high.
Formula Check all mandatory Forms (Pages) if Forms (Pages) are filled or empty. Calculate Number of Empty Forms (Pages). Divide the number of Empty Forms (Pages) by Total number of Forms (Pages) expected. Multiply by 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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