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
High Percentage of Missing eCRF Entries
Percent of missing data points
What level should be measured
(S)AE, Med History, Conmed fields should't be used in calculation of this KRI as well as unscheduled visits.
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.
The KRI controls exceeding percent of missing eCRF entries. It alarms if the calculated percent is too high.
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
Suggested Thresholds - Medium
Associated Metric 1
Number of expected CRF fields (per visit)
Associated Metric 2
Number of actual CRF fields (per visit)
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