Underreporting of Reported (S)AEs

Underreporting of Reported (S)AEs (kri)
Type of indicator Risk
Risk Category safety
Golden KRI YES
Therapeutic Area General
IF Risk-Event (S)AE underreporting happens
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT poor data integrity, jeopardy of Subject safety
Risk Indicator Underreporting of Reported (S)AEs
Metric Percent of Difference of Rate of (S)AE For Site And Average Rate For Study (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 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), 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 low 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 <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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