High Percentage of Data Point Corrections

High Percentage of Data Point Corrections
Type of indicator Performance
Risk Category Data Management
Golden KRI YES
Therapeutic Area General
IF Risk-Event A site makes frequently high number of data corrections in the EDC or other systems
DUE TO Risk Causes overload or other reasons
THEN Risk Impact MAY RESULT low trust in the data (study results) and potential regulatory audits
Risk Indicator High Percentage of Data Point Corrections
Metric Percentage of Data Points Corrected Often
Unit %
What level should be measured Study, Country, Site, Subject, Visit
Purpose Maintain data integrity, and uphold ethical and regulatory standards in clinical trials or research studies.
Description This KRI monitors the number of field corrections. If many fields exceed the allowed number of corrections (e.g., only 0 or 1 correction is permitted), it triggers an alert.
Formula Divide a value of metric Number of Data Points Corrected Often by a value of Number of Data Points for the same date and multiply by 100. Use values from the same date.
Suggested Thresholds - High 4%
Suggested Thresholds - Medium 3%
Associated Metric 1 Number of Data Points Corrected Often
Associated Metric 2 Number of Data Points
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