{
  "_id": "6acc9c1ba14063b82c3a6cfb",
  "Package": "r4subprofile",
  "Title": "Regulatory Authority Profiles for Submission Readiness",
  "Version": "0.3.0",
  "Authors@R": "person(\"Pawan Rama\", \"Mali\", email = \"prm@outlook.in\",\nrole = c(\"aut\", \"cre\", \"cph\"),\ncomment = c(ORCID = \"0000-0001-7864-5819\"))",
  "Description": "Defines submission profiles per regulatory authority with\nauthority-specific pillar weights, decision thresholds,\nindicator requirements, and risk configuration. Supports the\nU.S. Food and Drug Administration (FDA), European Medicines\nAgency (EMA), Pharmaceuticals and Medical Devices Agency\n(PMDA), Health Canada, Therapeutic Goods Administration (TGA),\nand Medicines and Healthcare products Regulatory Agency (MHRA).\nIntegrates with 'r4subscore' and 'r4subrisk' configuration\nsystems.",
  "License": "MIT + file LICENSE",
  "URL": "https://r4sub.github.io/r4subprofile/,\nhttps://github.com/R4SUB/r4subprofile",
  "BugReports": "https://github.com/R4SUB/r4subprofile/issues",
  "VignetteBuilder": "knitr",
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  "Encoding": "UTF-8",
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  "RoxygenNote": "7.3.3",
  "Config/pak/sysreqs": "libxml2-dev",
  "Repository": "https://r4sub.r-universe.dev",
  "Date/Publication": "2026-09-12 00:21:01 UTC",
  "RemoteUrl": "https://github.com/r4sub/r4subprofile",
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  "NeedsCompilation": "no",
  "Packaged": {
    "Date": "2026-10-12 08:33:09 UTC",
    "User": "root"
  },
  "Author": "Pawan Rama Mali [aut, cre, cph] (ORCID:\n<https://orcid.org/0000-0001-7864-5819>)",
  "Maintainer": "Pawan Rama Mali <prm@outlook.in>",
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  "_created": "2026-10-12T08:33:09.000Z",
  "_published": "2026-10-12T08:36:43.567Z",
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  "_host": "GitHub-Actions",
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    "author": "Pawan Rama Mali <prm@outlook.in>",
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    },
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  "_contributors": [
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    "type": "organization",
    "name": "R4SUB",
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    "description": "A framework to quantify clinical data readiness for regulatory submission"
  },
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  },
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  "_pkgdown": "https://r4sub.github.io/r4subprofile/",
  "_searchresults": 0,
  "_rbuild": "4.6.1",
  "_assets": [
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    "extra/citation.html",
    "extra/citation.json",
    "extra/citation.txt",
    "extra/contents.json",
    "extra/manual.pdf",
    "extra/NEWS.html",
    "extra/NEWS.txt",
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    "extra/readme.html",
    "extra/readme.md",
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  "_realowner": "r4sub",
  "_cranurl": true,
  "_releases": [
    {
      "version": "0.1.0",
      "date": "2026-03-03"
    }
  ],
  "_exports": [
    "compare_authorities",
    "list_authorities",
    "list_submission_types",
    "profile_required_indicators",
    "profile_risk_config",
    "profile_sci_config",
    "profile_summary",
    "rule_pack",
    "rule_pack_indicators",
    "rule_pack_provenance",
    "rule_packs",
    "submission_profile",
    "validate_against_profile"
  ],
  "_help": [
    {
      "page": "compare_authorities",
      "title": "Compare Submission Profiles Across Authorities",
      "topics": [
        "compare_authorities"
      ]
    },
    {
      "page": "list_authorities",
      "title": "List Supported Regulatory Authorities",
      "topics": [
        "list_authorities"
      ]
    },
    {
      "page": "list_submission_types",
      "title": "List Submission Types for an Authority",
      "topics": [
        "list_submission_types"
      ]
    },
    {
      "page": "profile_required_indicators",
      "title": "Get Required Indicators for a Profile",
      "topics": [
        "profile_required_indicators"
      ]
    },
    {
      "page": "profile_risk_config",
      "title": "Extract Risk Configuration from a Profile",
      "topics": [
        "profile_risk_config"
      ]
    },
    {
      "page": "profile_sci_config",
      "title": "Extract SCI Configuration from a Profile",
      "topics": [
        "profile_sci_config"
      ]
    },
    {
      "page": "profile_summary",
      "title": "Summarize a Submission Profile",
      "topics": [
        "profile_summary"
      ]
    },
    {
      "page": "rule_pack",
      "title": "Select a Rule Pack",
      "topics": [
        "print.rule_pack",
        "rule_pack"
      ]
    },
    {
      "page": "rule_pack_indicators",
      "title": "Indicators in a Rule Pack",
      "topics": [
        "rule_pack_indicators"
      ]
    },
    {
      "page": "rule_pack_provenance",
      "title": "Provenance of a Rule Pack",
      "topics": [
        "rule_pack_provenance"
      ]
    },
    {
      "page": "rule_packs",
      "title": "Available Rule Packs",
      "topics": [
        "rule_packs"
      ]
    },
    {
      "page": "submission_profile",
      "title": "Create a Submission Profile",
      "topics": [
        "submission_profile"
      ]
    },
    {
      "page": "validate_against_profile",
      "title": "Validate Evidence Against a Submission Profile",
      "topics": [
        "validate_against_profile"
      ]
    }
  ],
  "_readme": "https://github.com/r4sub/r4subprofile/raw/HEAD/README.md",
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    "tibble",
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    "xml2"
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      "headings": [
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        "Submission types per authority",
        "Creating a submission profile",
        "Comparing authority weights",
        "Profile summary",
        "Validating evidence against a profile",
        "Study phase",
        "Versioned rule packs"
      ],
      "created": "2026-03-16 08:52:42",
      "modified": "2026-08-04 23:31:50",
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