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Monitoring of Adverse Event (AE) reporting in clinical trials is important for patient safety. Sites that are under-reporting AEs can be detected using Bootstrap-based simulations that simulate overall AE reporting. Based on the simulation an AE under-reporting probability is assigned to each site in a given trial (Koneswarakantha 2021 <doi:10.1007/s40264-020-01011-5>).
Package details |
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Author | Bjoern Koneswarakantha [aut, cre, cph] (<https://orcid.org/0000-0003-4585-7799>), F. Hoffmann-La Roche Ltd [cph] |
Maintainer | Bjoern Koneswarakantha <bjoern.koneswarakantha@roche.com> |
License | MIT + file LICENSE |
Version | 0.7.0 |
URL | https://openpharma.github.io/simaerep/ https://github.com/openpharma/simaerep/ |
Package repository | View on CRAN |
Installation |
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