simaerep (Q72579)
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Detect Clinical Trial Sites Over- or Under-Reporting Clinical Events
| Language | Label | Description | Also known as |
|---|---|---|---|
| default for all languages | No label defined |
||
| English | simaerep |
Detect Clinical Trial Sites Over- or Under-Reporting Clinical Events |
Statements
28 October 2025
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Monitoring reporting rates of subject-level clinical events (e.g. adverse events, protocol deviations) reported by clinical trial sites is an important aspect of risk-based quality monitoring strategy. Sites that are under-reporting or over-reporting events can be detected using bootstrap simulations during which patients are redistributed between sites. Site-specific distributions of event reporting rates are generated that are used to assign probabilities to the observed reporting rates. (Koneswarakantha 2024 <doi:10.1007/s43441-024-00631-8>).
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