{
  "_id": "6a1eedf2b401979e734128a2",
  "Package": "eudract",
  "Type": "Package",
  "Title": "Creates Safety Results Summary in XML to Upload to EudraCT, or\nClinicalTrials.gov",
  "Date": "2026-01-15",
  "Version": "1.1.1",
  "Authors@R": "c(\nperson(\"Simon\", \"Bond\", email=\"simon.bond7@nhs.net\", role=\"cre\"),\nperson(\"Beatrice\",\"Pantaleo\", email=\"bp403@medschl.cam.ac.uk\", role=\"aut\"))",
  "URL": "https://eudract-tool.medschl.cam.ac.uk/,\nhttps://shug0131.github.io/eudraCT/",
  "BugReports": "https://github.com/shug0131/eudraCT/issues",
  "Description": "The remit of the European Clinical Trials Data Base\n(EudraCT <https://eudract.ema.europa.eu/> ), or\nClinicalTrials.gov <https://clinicaltrials.gov/>, is to provide\nopen access to summaries of all registered clinical trial\nresults; thus aiming to prevent non-reporting of negative\nresults and provide open-access to results to inform future\nresearch. The amount of information required and the format of\nthe results, however, imposes a large extra workload at the end\nof studies on clinical trial units. In particular, the\nadverse-event-reporting component requires entering: each\nunique combination of treatment group and safety event; for\nevery such event above, a further 4 pieces of information (body\nsystem, number of occurrences, number of subjects, number\nexposed) for non-serious events, plus an extra three pieces of\ndata for serious adverse events (numbers of causally related\nevents, deaths, causally related deaths). This package prepares\nthe required statistics needed by EudraCT and formats them into\nthe precise requirements to directly upload an XML file into\nthe web portal, with no further data entry by hand.",
  "License": "GPL-2",
  "Language": "en-GB",
  "Encoding": "UTF-8",
  "LazyData": "true",
  "RoxygenNote": "7.3.3",
  "VignetteBuilder": "knitr",
  "NeedsCompilation": "no",
  "Packaged": {
    "Date": "2026-05-19 08:56:16 UTC",
    "User": "root"
  },
  "Author": "Simon Bond [cre], Beatrice Pantaleo [aut]",
  "Maintainer": "Simon Bond <simon.bond7@nhs.net>",
  "Repository": "https://cran.r-universe.dev",
  "Date/Publication": "2026-01-19 20:41:11 UTC",
  "RemoteUrl": "https://github.com/cran/eudract",
  "RemoteRef": "HEAD",
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  "_published": "2026-06-02T14:51:30.435Z",
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  "_status": "success",
  "_host": "GitHub-Actions",
  "_upstream": "https://github.com/cran/eudract",
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    "author": "Simon Bond <simon.bond7@nhs.net>",
    "committer": "cran-robot <csardi.gabor+cran@gmail.com>",
    "message": "version 1.1.1\n",
    "time": 1768855271
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    "name": "Simon Bond",
    "email": "simon.bond7@nhs.net"
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  "_updates": [
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    "name": "cran",
    "description": "Unofficial read-only mirror of all CRAN R packages"
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    "source": "https://cranlogs.r-pkg.org/downloads/total/last-month/eudract"
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  "_devurl": "https://github.com/shug0131/eudract",
  "_searchresults": 32,
  "_rbuild": "4.6.0",
  "_assets": [
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    "extra/citation.html",
    "extra/citation.json",
    "extra/citation.txt",
    "extra/contents.json",
    "extra/eudract.html",
    "extra/NEWS.html",
    "extra/NEWS.txt",
    "extra/readme.html",
    "extra/readme.md",
    "manual.pdf"
  ],
  "_realowner": "cran",
  "_cranurl": false,
  "_releases": [
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      "version": "0.9.0",
      "date": "2019-11-07"
    },
    {
      "version": "0.9.1",
      "date": "2020-02-13"
    },
    {
      "version": "0.9.2",
      "date": "2020-04-06"
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    {
      "version": "0.9.3",
      "date": "2021-02-24"
    },
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      "date": "2023-08-09"
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      "version": "1.0.1",
      "date": "2024-08-26"
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      "date": "2025-03-22"
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  ],
  "_exports": [
    "clintrials_gov_convert",
    "clintrials_gov_upload",
    "create.safety_summary",
    "dot_plot",
    "eudract_convert",
    "incidence_table",
    "order_filter",
    "relative_risk",
    "relative_risk_table",
    "safety_summary",
    "safety_summary_adam",
    "simple_safety_xml"
  ],
  "_datasets": [
    {
      "name": "safety",
      "title": "Example of safety data",
      "object": "safety",
      "class": [
        "data.frame"
      ],
      "fields": [
        "pt",
        "subjid",
        "related",
        "soc",
        "fatal",
        "serious",
        "group",
        "term"
      ],
      "rows": 116,
      "table": true,
      "tojson": true
    },
    {
      "name": "soc_code",
      "title": "System Organ Class coding",
      "object": "soc_code",
      "class": [
        "data.frame"
      ],
      "fields": [
        "soc_term",
        "eutctId",
        "meddra"
      ],
      "rows": 27,
      "table": true,
      "tojson": true
    }
  ],
  "_help": [
    {
      "page": "clintrials_gov_convert",
      "title": "applies a conversion using xslt from a simple xml file to a ClinicalTrials.gov compatible file, and checks against the schema",
      "topics": [
        "clintrials_gov_convert"
      ]
    },
    {
      "page": "clintrials_gov_upload",
      "title": "applies a conversion using xslt from a simple xml file to a ClinicalTrials.gov compatible file, merges into a study record from the portal, and uploads the result.",
      "topics": [
        "clintrials_gov_upload"
      ]
    },
    {
      "page": "create.safety_summary",
      "title": "function that creates a safety_summary object from individual data.frames",
      "topics": [
        "create.safety_summary"
      ]
    },
    {
      "page": "dot_plot",
      "title": "creates a dot-plot of safety data showing the absolute and relative risks",
      "topics": [
        "dot_plot"
      ]
    },
    {
      "page": "eudract_convert",
      "title": "applies a conversion using xslt from a simple xml file to a eudract compatible file, and checks against the schema",
      "topics": [
        "eudract_convert"
      ]
    },
    {
      "page": "incidence_table",
      "title": "provide standard structured tables to report incidence rates of AEs by arm",
      "topics": [
        "incidence_table"
      ]
    },
    {
      "page": "plot.dot_plot",
      "title": "plot methods for dot_plot object",
      "topics": [
        "plot.dot_plot"
      ]
    },
    {
      "page": "print.dot_plot",
      "title": "print methods for dot_plot object",
      "topics": [
        "print.dot_plot"
      ]
    },
    {
      "page": "relative_risk",
      "title": "Calculate relative risks to be reported or plotted as dot plot",
      "topics": [
        "order_filter",
        "relative_risk",
        "relative_risk_table"
      ]
    },
    {
      "page": "safety",
      "title": "Example of safety data",
      "topics": [
        "safety"
      ]
    },
    {
      "page": "safety_summary",
      "title": "Calculate frequency tables from a rectangular data frame with one row per subject-event",
      "topics": [
        "safety_summary"
      ]
    },
    {
      "page": "safety_summary_adam",
      "title": "Calculate frequency tables based on ADaM data.",
      "topics": [
        "safety_summary_adam"
      ]
    },
    {
      "page": "simple_safety_xml",
      "title": "creates a simple xml file from the input of a safety_summary object",
      "topics": [
        "simple_safety_xml"
      ]
    },
    {
      "page": "soc_code",
      "title": "System Organ Class coding",
      "topics": [
        "soc_code"
      ]
    }
  ],
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    "curl",
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  "_vignettes": [
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      "source": "eudract.Rmd",
      "filename": "eudract.html",
      "title": "Eudract and CT.gov Safety XML",
      "author": "Simon Bond",
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      "headings": [
        "Introduction",
        "Safety data set",
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