High Percentage of Failed ePRO Devices

High Percentage of Failed ePRO Devices (kri)
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 Devide a number of Subjects with device failures by number of enrolled Subjects, multipy 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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