A high proportion of datapoints have not been entered into the eCRF
DUE TO Risk Causes
System challenges or workload at the sites
THEN Risk Impact MAY RESULT
Lack of data to monitor for potential issues meaning a potential delay in detecting serious concerns. When nearing database lock it may cause a study delay.
Risk Indicator
High percentage of missing eCRF entries
Metric
Percent of missing data points
Unit
%
What level should be measured
Study, Country, Site
Comment
As this is a measurement against expected data entry fields, unscheduled visits, (S)AE, medical history, and concomitant medication fields are not included in the calculation.
Purpose
Delays in data entry by sites mean that the data cannot be assessed centrally in a timely way. This may cause delays in detection of serious concerns. In addition, while the data remains unentered, the accuracy of its entry into the eCRF may reduce. This KRI does not indicate whether the data is unavailable or has simply not yet been entered - follow-up will be needed to determine this.
Description
This KRI monitors the risk of a high proportion of missing eCRF data. It alarms if value is higher than expected.
Formula
(Sum Empty eCRF Fields) / (Sum Empty eCRF Fields + Sum Complete eCRF Fields) x 100. Include only mandatory fields across all forms (using 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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