Poor data integrity and jeopardy of subject safety
Risk Indicator
Underreporting of Reported (S)AEs
Metric
Percent Difference of (S)AE Rate vs Study Average (Negated)
Unit
%
What level should be measured
Study, Country, Site
Purpose
Monitoring safety is critical in a clinical trial. By monitoring the number of (S)AEs reported per subject visit and comparing between sites, it is possible to detect sites that are either reporting unusually high or low levels of (S)AEs. These outlier sites need investigation as it may be that the protocol is not being followed (e.g., the same AE is being reported multiple times, multiple AEs are being reported as one AE), or that the trial subjects at those sites are generally healthier (or less healthy) than at other sites. Investigation is needed to determine if further follow-up and correction is required.
Description
This KRI monitors whether a site is reporting a relatively low number of (S)AEs compared with other sites in the trial. The KRI alarms if the rate is too high or too low compared with other sites.
Formula
Compute the absolute percent difference between the entity’s AE rate and the study-level AE rate: |Rateentity − Ratestudy| / Ratestudy × 100. Use values from the same date.
Suggested Thresholds - High
70%
Suggested Thresholds - Medium
80%
Associated Metric 1
Number of SAEs
Associated Metric 2
Number of AEs
Associated Metric 3
Number of Visits
Associated Metric 4
Rate of AE per visit
Associated Metric 5
Rate of SAE per visit
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