High Percentage of Missing Outcomes/Endpoints

High Percentage of Missing Outcomes/Endpoints Table

High Percentage of Missing Outcomes/Endpoints

Type of indicator Performance
Risk Category Study Endpoints
Golden KRI Yes
Therapeutic Area General
IF Risk-Event Too much outcome data is missing
DUE TO Risk Causes Assessments have been missed or other reasons
THEN Risk Impact MAY RESULT The outcome of the study might be inconclusive.
Risk Indicator High percentage of missing outcomes/endpoints
Metric Percent of missing outcomes
Unit %
What level should be measured Study, Country, Site
Purpose Outcomes/endpoint data for the primary (or key secondary) endpoints are needed to determine investigational product efficacy. If too much of this critical data is missing, it may not be possible to draw a conclusion from the study and the time and efforts of all involved and the risk taken by participants will have been of no value. This KRI does not inform as to whether the data is not available or has simply not yet been entered - follow-up will be needed to determine this.
Description The KRI monitors the risk of a high level of missing outcomes/endpoint data. It alarms if the rate is higher than expected.
Formula (Sum Empty eCRF Fields)/(Sum Empty eCRF Fields + Sum Complete eCRF Fields)x100. Include only fields that are outcome fields (following Study Outcomes file information in Study settings → Study Protocol)
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of empty eCRF fields (mandatory, outcome)
Associated Metric 2 Number of complete eCRF fields (mandatory, outcome)
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