Overreporting of Reported (S)AEs
| Type of indicator | Risk |
|---|---|
| Risk category | Safety |
| Golden KRI | NO |
| Therapeutic area | General |
| IF risk event | A site reports substantially more (serious) adverse events ((S)AEs) compared to other sites participating in the same study |
| DUE TO risk causes | Misunderstanding of (S)AE reporting criteria, inconsistent application of definitions, differing approaches to collecting AE data from participants, or duplicate reporting |
| THEN risk impact may result | Increased uncertainty about the investigational product’s safety profile, potential misinterpretation of data, and regulatory challenges during submission or approval |
| Risk indicator | Overreporting of reported (S)AEs |
| Metric | Rate of (S)AEs per site |
| Unit | % |
| What level should be measured | Study, country, site |
| Purpose | Ensure consistent safety reporting practices across all study sites and detect potential outliers whose reporting behavior may indicate procedural misunderstandings, duplicate reporting, or differing standards of AE assessment. |
| Description | This KRI evaluates whether a site’s (S)AE reporting rate is disproportionately higher than that of other study sites, signaling potential protocol non-adherence or inconsistent safety data collection methods. |
| Formula | Calculate the percentage difference between the rate of (S)AEs at the site (entity) and the average rate of (S)AEs across the study. Express the absolute difference relative to the study-level rate: ((|site AE rate − study AE rate| ÷ study AE rate) × 100%). |
| Suggested thresholds - high | 130% |
| Suggested thresholds - medium | 120% |
| Associated metric 1 | Number of serious adverse events (SAEs) |
| Associated metric 2 | Number of adverse events (AEs) |
| Associated metric 3 | Number of participant visits |
| Associated metric 4 | Rate of AEs per visit |
| Associated metric 5 | Rate of SAEs per visit |