simaerep

MaRDI QIDQ72579CRANFDO

Authors Bjoern Koneswarakantha

Last update 28 October 2025

Copyright license MIT license, File License

Software version identifier 0.4.3, PACKAGES.rds, 0.4.2, 0.5.0, 0.6.0, 0.7.0, 1.0.0

Description

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>).

Cites work

• An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium

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