{
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  "Package": "simaerep",
  "Title": "Detect Clinical Trial Sites Over- or Under-Reporting Clinical\nEvents",
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  "Authors@R": "c(\nperson(given = \"Bjoern\",\nfamily = \"Koneswarakantha\",\nrole = c(\"aut\", \"cre\", \"cph\"),\nemail = \"bjoern.koneswarakantha@roche.com\",\ncomment = c(ORCID = \"0000-0003-4585-7799\")),\nperson(\"F. Hoffmann-La Roche Ltd\",\nrole = c(\"cph\"))\n)",
  "Description": "Monitoring reporting rates of subject-level clinical\nevents (e.g. adverse events, protocol deviations) reported by\nclinical trial sites is an important aspect of risk-based\nquality monitoring strategy. Sites that are under-reporting or\nover-reporting events can be detected using bootstrap\nsimulations during which patients are redistributed between\nsites. Site-specific distributions of event reporting rates are\ngenerated that are used to assign probabilities to the observed\nreporting rates. (Koneswarakantha 2024\n<doi:10.1007/s43441-024-00631-8>).",
  "URL": "https://openpharma.github.io/simaerep/,\nhttps://github.com/openpharma/simaerep/",
  "License": "MIT + file LICENSE",
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  "Language": "en-US",
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  "Repository": "https://pharmaverse.r-universe.dev",
  "Date/Publication": "2026-09-28 15:35:50 UTC",
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    "User": "root"
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  "Author": "Bjoern Koneswarakantha [aut, cre, cph] (ORCID:\n<https://orcid.org/0000-0003-4585-7799>),\nF. Hoffmann-La Roche Ltd [cph]",
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  "_created": "2026-09-28T15:46:02.000Z",
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    "author": "Björn Oettinghaus <bjoern.koneswarakantha@roche.com>",
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    "message": "Merge pull request #101 from openpharma/erblast-patch-3\n\nUpdate validation.yml",
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    "clinical-trials"
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