High Percentage of Subjects with poor quality ECGs
High Percentage of Subjects with Poor Quality ECGs Table
Type of indicator
Performance
Risk category
Technology
Golden KRI
NO
Therapeutic area
General
IF risk event
A high percentage of ECGs contain suspicious or poor-quality data
DUE TO risk causes
Incorrect placement of ECG leads or equipment malfunction
THEN risk impact may result
ECG data may be unusable for analysis, leading to compromised subject safety and unreliable study results
Risk indicator
High percentage of subjects with poor-quality ECGs
Metric
Percentage of subjects with poor-quality ECGs
Unit
%
What level should be measured
Study, country, site
Purpose
Ensure the reliability and accuracy of ECG data collected in clinical trials. Reliable ECG readings are critical for monitoring cardiovascular safety and ensuring valid study outcomes.
Description
This KRI tracks the proportion of subjects whose ECG data is of poor quality due to technical or procedural issues. A high percentage indicates the need for site retraining or equipment verification.
Formula
(Number of subjects with at least one poor-quality ECG ÷ Total number of enrolled subjects) × 100%
Suggested thresholds - high
5%
Suggested thresholds - medium
3%
Associated metric 1
Number of subjects with at least one poor-quality ECG
Associated metric 2
Number of enrolled subjects
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