A site reports many more (S)AEs compared to other sites
DUE TO Risk Causes
Misunderstanding of (S)AE reporting requirements or a different approach to gathering AE data from trial participants
THEN Risk Impact MAY RESULT
More uncertainty around the compound's safety profile and potential issues when applying for approval.
Risk Indicator
Overreporting of Reported (S)AEs
Metric
Rate of (S)AE for site
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 participant 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), the approach to gathering AE data from trial participants is very different to other sites or that the trial participants 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 high number of (S)AEs compared with other sites in the trial. The KRI alarms if the rate is too high (or low) compared with other sites.
Formula
Calculate the percent of absolute difference between Rate of AE (at the study level) and Rate of AE (in entity) relatively to the former.
Suggested Thresholds - High
>130 %
Suggested Thresholds - Medium
>120%
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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