simaerep: Detect Clinical Trial Sites Over- or Under-Reporting Clinical Events
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>).
| Version: | 1.0.0 |
| 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 |
| Published: | 2025-10-28 |
| DOI: | 10.32614/CRAN.package.simaerep |
| Author: | Bjoern Koneswarakantha
 [aut, cre,
cph],
F. Hoffmann-La Roche Ltd [cph] |
| Maintainer: | Bjoern Koneswarakantha <bjoern.koneswarakantha at roche.com> |
| License: | MIT + file LICENSE |
| URL: | https://openpharma.github.io/simaerep/, https://github.com/openpharma/simaerep/ |
| NeedsCompilation: | no |
| Language: | en-US |
| Materials: | README, NEWS |
| CRAN checks: | simaerep results |
Documentation:
| Reference manual: | simaerep.html , simaerep.pdf |
Downloads:
| Package source: | simaerep_1.0.0.tar.gz |
| Windows binaries: | r-devel: simaerep_1.0.0.zip, r-release: simaerep_1.0.0.zip, r-oldrel: simaerep_1.0.0.zip |
| macOS binaries: | r-release (arm64): simaerep_1.0.0.tgz, r-oldrel (arm64): simaerep_1.0.0.tgz, r-release (x86_64): simaerep_1.0.0.tgz, r-oldrel (x86_64): simaerep_1.0.0.tgz |
| Old sources: | simaerep archive |
Linking:
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