High Percentage of Failed ePRO Devices


High Percentage of Failed ePRO Devices Table

High Percentage of Failed ePRO Devices

Type of indicator Risk
Risk Category Technology
Golden KRI NO
Therapeutic Area General
IF Risk-Event ePRO devices or the Subjects’ own devices fail
DUE TO Risk Causes Hardware problems/technical issues/connectivity/misunderstanding of ePRO completion occur
THEN Risk Impact MAY RESULT A lack of data availability
Risk Indicator High Percentage of Failed ePRO Devices
Metric Percent of Failed ePRO Devices
Unit %
What level should be measured Study, Country, Site
Purpose Ensure the effective and reliable collection of Subject-reported data using ePRO devices, facilitating accurate assessments, monitoring treatment outcomes, and improving patient care.
Description KRI monitors the occurrence of failures or malfunctions in electronic Subject-Reported Outcome (ePRO) devices used for data collection, ensuring reliable and uninterrupted capture of Subject-reported data in healthcare or research settings.
Formula Divide the number of Subjects with device failures by the number of enrolled Subjects, multiply by 100%.
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of Subjects with device failures
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