{
  "_id": "6aba962a99f7aa8c6aa41b6c",
  "Package": "simaerep",
  "Title": "Detect Clinical Trial Sites Over- or Under-Reporting Clinical\nEvents",
  "Version": "1.0.0",
  "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",
  "Encoding": "UTF-8",
  "Roxygen": "list(markdown = TRUE)",
  "RoxygenNote": "7.3.2",
  "Language": "en-US",
  "Config/testthat/edition": "3",
  "Config/pak/sysreqs": "libicu-dev",
  "Repository": "https://openpharma.r-universe.dev",
  "Date/Publication": "2026-09-28 15:35:50 UTC",
  "RemoteUrl": "https://github.com/openpharma/simaerep",
  "RemoteRef": "HEAD",
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  "Packaged": {
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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]",
  "Maintainer": "Bjoern Koneswarakantha <bjoern.koneswarakantha@roche.com>",
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  "_type": "src",
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  "_expires": "2027-01-06T16:30:30.000Z",
  "_created": "2026-09-28T16:05:28.000Z",
  "_published": "2026-09-28T16:30:33.848Z",
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  "_buildurl": "https://github.com/r-universe/openpharma/actions/runs/36447773161",
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    "author": "Björn Oettinghaus <bjoern.koneswarakantha@roche.com>",
    "committer": "GitHub <noreply@github.com>",
    "message": "Merge pull request #101 from openpharma/erblast-patch-3\n\nUpdate validation.yml",
    "time": 1790609750
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    "orcid": "0000-0003-4585-7799",
    "description": "",
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  "_selfowned": true,
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      "date": "2026-09-28"
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    "clinical-trials"
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      "uuid": 14346503
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    "type": "organization",
    "name": "openpharma",
    "followers": 265,
    "description": "Further precompetitive collaboration in life sciences"
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    "extra/citation.html",
    "extra/citation.json",
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  "_realowner": "openpharma",
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      "date": "2023-02-25"
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    "plot_sim_example",
    "plot_sim_examples",
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    "sim_inframe",
    "sim_out",
    "sim_sites",
    "sim_test_data_patient",
    "sim_test_data_portfolio",
    "sim_test_data_study",
    "simaerep",
    "simaerep_classic",
    "simaerep_inframe",
    "site_aggr",
    "with_progress_cnd"
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      "title": "Get cumulative mean event development",
      "topics": [
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      "title": "Get Portfolio Configuration",
      "topics": [
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      "page": "get_portf_event_rates",
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      "topics": [
        "get_portf_event_rates"
      ]
    },
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      "page": "orivisit",
      "title": "create orivisit object",
      "topics": [
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      ]
    },
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      "page": "plot_dots",
      "title": "Plots AE per site as dots.",
      "topics": [
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    },
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      "title": "Plot simulation example.",
      "topics": [
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    },
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      "page": "plot.simaerep",
      "title": "plot AE under-reporting simulation results",
      "topics": [
        "plot.simaerep"
      ]
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      "title": "Execute a purrr or furrr function with a progress bar.",
      "topics": [
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      ]
    },
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      "page": "sim_inframe",
      "title": "Calculate prob for study sites using table operations",
      "topics": [
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      "page": "sim_out",
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      "topics": [
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      "title": "Calculate prob_lower and poisson.test pvalue for study sites.",
      "topics": [
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      ]
    },
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      "page": "sim_test_data_portfolio",
      "title": "Simulate Portfolio Test Data",
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    },
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      "title": "simulate study test data",
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    },
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      "title": "Create simaerep object",
      "topics": [
        "simaerep",
        "simaerep_classic",
        "simaerep_inframe"
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    },
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      "page": "site_aggr",
      "title": "Aggregate from visit to site level.",
      "topics": [
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