High Percentage of Missing eCRF Entries

High Percentage of Missing eCRF Entries (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI YES
Therapeutic Area General
IF Risk-Event a high number of datapoints have not been entered into the eCRF
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 eCRF Entries
Metric Percent of missing data points
Unit %
What level should be measured Study/Country/Site
Comment (S)AE, Med History, Conmed fields should't be used in calculation of this KRI as well as unscheduled 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 eCRF entries. It alarms if the calculated percent is too high.
Formula Check all forms (Pages) mandatory fields (following METADATA specification) if fields are filled or empty. Calculate Number of Empty fields. Divide the number of Empty fields by Total number of fields expected. Multiply by 100%.
Suggested Thresholds - High >20 %
Suggested Thresholds - Medium >10 %
Associated Metric 1 Number of expected CRF fields (per visit)
Associated Metric 2 Number of actual CRF fields (per visit)
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