High Percentage of Missing Outcomes/Endpoints

High Percentage of Missing Outcomes/Endpoints (kri)
Type of indicator Performance
Risk Category study endpoints
Golden KRI YES
Therapeutic Area General
IF Risk-Event outcome data is missing
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT the non-acceptance of the Study by health authorities
Risk Indicator High Percentage of Missing Outcomes/Endpoints
Metric Percent of missing outcomes
Unit %
What level should be measured Study,Country,Site
Purpose Outcomes/Endpoints are the most important data in a study besides the safety data. They usually are the primary efficacy data (or important secondary efficacy data). If many of these data are missing the outcome of a study may be inconclusive.
Description The KRI controls exceeding Percentage of Missing Outcomes. It alarms if the calculated rate is too high.
Formula Check all forms (Pages) mandatory fields (following Study Outcomes file information in Study settings → Study Protocol) if fields are filled or empty. Calculate Number of empty fields. Devide the number of Empty fields by Total number of fields expected. Multiply by 100.
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of expected Outcome/Endpoint fields (considering visit schedule)
Associated Metric 2 Number of actual Outcome/Endpoint fields (considering visit schedule)
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