Detect Clinical Trial Sites Over- or Under-Reporting Clinical Events R package simaerep version 1.0.0 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>). Software Depends: R (>= 4.0), ggplot2 Imports: dplyr (>= 1.1.0), tidyr (>= 1.1.0), magrittr, purrr, rlang, stringr, forcats, cowplot, RColorBrewer, furrr (>= 0.2.1), progressr, knitr, tibble, dbplyr, glue Suggests: testthat, devtools, pkgdown, spelling, haven, vdiffr, lintr, DBI, duckdb, ggExtra Bjoern Koneswarakantha <bjoern.koneswarakantha@roche.com> Comprehensive R Archive Network (CRAN) Bjoern Koneswarakantha [aut, cre, cph] (ORCID: <https://orcid.org/0000-0003-4585-7799>), F. Hoffmann-La Roche Ltd [cph] MIT + file LICENSE (https://CRAN.R-project.org/package=simaerep/LICENSE) 2025-10-28 application/tgz https://CRAN.R-project.org/package=simaerep doi:10.32614/CRAN.package.simaerep en-US