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 |