{ "_id": "6ad92a9bc230b829876fd4fb", "Package": "openstudyval", "Type": "Package", "Title": "Open Validator for FDA Study-Data Submissions", "Version": "0.1.1", "Authors@R": "person(given = \"Shekhar Eranna\", family = \"Chalwadi\",\nemail = \"skrchalwadicg@gmail.com\",\nrole = c(\"aut\", \"cre\"))", "Description": "Validates clinical and nonclinical study-data packages\nagainst publicly described FDA technical-rejection criteria,\nSAS XPORT constraints from the Study Data Technical Conformance\nGuide, and an extensible catalog of SDTM, SEND, and ADaM\nstructural conformance checks. Reads a study folder of CSV,\nRDS, or (when the suggested package haven is installed) SAS\nv5/v8 transport files, optionally checks define.xml, and writes\na submission-style HTML and CSV validation report. This package\nis an independent open-source implementation. It is not\naffiliated with, endorsed by, or a copy of Pinnacle 21,\nCertara, or the FDA.", "License": "MIT + file LICENSE", "URL": "https://github.com/shekharchalwadigrepo-hub/openstudyval", "BugReports": "https://github.com/shekharchalwadigrepo-hub/openstudyval/issues", "Encoding": "UTF-8", "Language": "en-US", "VignetteBuilder": "knitr", "Config/testthat/edition": "3", "RoxygenNote": "7.3.2", "NeedsCompilation": "no", "Packaged": { "Date": "2026-10-21 21:08:22 UTC", "User": "root" }, "Author": "Shekhar Eranna Chalwadi [aut, cre]", "Maintainer": "Shekhar Eranna Chalwadi ", "Repository": "https://cran.r-universe.dev", "Date/Publication": "2026-10-21 16:30:02 UTC", "RemoteUrl": "https://github.com/cran/openstudyval", "RemoteRef": "HEAD", "RemoteSha": "3a9f2dd8e3a8b0aa19efd880ba6b845a7876cbc4", "_user": "cran", "_type": "src", "_file": "openstudyval_0.1.1.tar.gz", "_fileid": "https://r2.ropensci.org/2720a16fc318b1b852d70099bb1c0f464ca14480f5d52405bf98dff52bdf54e8", "_filesize": 125955, "_sha256": "2720a16fc318b1b852d70099bb1c0f464ca14480f5d52405bf98dff52bdf54e8", "_expires": "2027-01-29T21:11:53.000Z", "_created": "2026-10-21T21:08:22.000Z", "_published": "2026-10-21T21:11:55.353Z", "_upstream": "https://github.com/cran/openstudyval", "_status": "success", "_maintainer": { "name": "Shekhar Eranna Chalwadi", "email": "skrchalwadicg@gmail.com", "login": "skchalwadicg", "description": "", "uuid": 149681124 }, "_jobs": [ { "job": 119487086331, "time": 121, "config": "linux-devel-x86_64", "r": "4.7.0", "check": "OK", "artifact": "12381657139" }, { "job": 119487086407, "time": 179, "config": "linux-release-x86_64", "r": "4.6.1", "check": "OK", "artifact": "12382477697" }, { "job": 119485255181, "time": 225, "config": "source", "r": "4.6.1", "check": "OK", "artifact": "12382487059" }, { "job": 119487086212, "time": 80, "config": "wasm-release", "r": "4.6.0", "check": "OK", "artifact": "12381647918" }, { "job": 119487086227, "time": 69, "config": "windows-devel-x86_64", "r": "4.7.0", "check": "OK", "artifact": "12381887843" }, { "job": 119487086188, "time": 65, "config": "windows-release-x86_64", "r": "4.6.1", "check": "OK", "artifact": "12382915261" } ], "_buildurl": "https://github.com/r-universe/cran/actions/runs/39675206106", "_commit": { "id": "3a9f2dd8e3a8b0aa19efd880ba6b845a7876cbc4", "author": "Shekhar Eranna Chalwadi ", "committer": "cran-robot ", "message": "version 0.1.1\n", "time": 1792600202 }, "_distro": "resolute", "_host": "GitHub-Actions", "_registered": true, "_dependencies": [ { "package": "R", "version": ">= 4.1.0", "role": "Depends" }, { "package": "stats", "role": "Imports" }, { "package": "tools", "role": "Imports" }, { "package": "utils", "role": "Imports" }, { "package": "haven", "role": "Suggests" }, { "package": "xml2", "role": "Suggests" }, { "package": "knitr", "role": "Suggests" }, { "package": "rmarkdown", "role": "Suggests" }, { "package": "testthat", "version": ">= 3.0.0", "role": "Suggests" } ], "_owner": "cran", "_selfowned": false, "_usedby": 0, "_updates": [ { "week": "2026-43", "n": 1 } ], "_tags": [ { "name": "0.1.1", "date": "2026-10-21" } ], "_stars": 0, "_contributors": [ { "user": "skchalwadicg", "count": 1, "uuid": 149681124 } ], "_userbio": { "uuid": 6899542, "type": "organization", "name": "cran", "followers": 634, "description": "Unofficial read-only mirror of all CRAN R packages" }, "_downloads": { "count": 0, "source": "https://cranlogs.r-pkg.org/downloads/total/last-month/openstudyval" }, "_devurl": "https://github.com/shekharchalwadigrepo-hub/openstudyval", "_searchresults": 0, "_rbuild": "4.6.1", "_assets": [ "extra/citation.cff", "extra/citation.html", "extra/citation.json", "extra/citation.txt", "extra/contents.json", "extra/manual.pdf", "extra/NEWS.html", "extra/NEWS.txt", "extra/openstudyval.html", "LICENSE" ], "_cranurl": false, "_releases": [ { "version": "0.1.1", "date": "2026-10-21" } ], "_exports": [ "add_custom_rules", "example_study", "explain_rule", "read_study_data", "rules_catalog", "severity_levels", "validate_datasets", "validate_submission", "write_validation_report" ], "_help": [ { "page": "openstudyval-package", "title": "Open validator for FDA study-data submissions", "topics": [ "openstudyval-package", "openstudyval" ] }, { "page": "example_study", "title": "Path to a bundled example study", "topics": [ "example_study" ] }, { "page": "osv_report", "title": "Validation report object", "topics": [ "as.data.frame.osv_report", "print.osv_report", "print.summary.osv_report", "summary.osv_report" ] }, { "page": "read_study_data", "title": "Read a study-data folder", "topics": [ "read_study_data" ] }, { "page": "rules_catalog", "title": "Rule catalog helpers", "topics": [ "add_custom_rules", "explain_rule", "rules_catalog", "severity_levels" ] }, { "page": "validate_datasets", "title": "Validate datasets already in memory", "topics": [ "validate_datasets" ] }, { "page": "validate_submission", "title": "Validate a study-data folder", "topics": [ "validate_submission" ] }, { "page": "write_validation_report", "title": "Write an HTML or CSV validation report", "topics": [ "write_validation_report" ] } ], "_rundeps": [], "_vignettes": [ { "source": "validating.Rmd", "filename": "validating.html", "title": "Validating an FDA study-data package", "engine": "knitr::rmarkdown", "headings": [ "What this package is", "Run the bundled example", "Add a study-specific rule" ], "created": "2026-10-21 16:30:02", "modified": "2026-10-21 16:30:02", "commits": 1 } ], "_score": 2, "_indexed": false, "_nocasepkg": "openstudyval", "_universes": [ "cran", "skchalwadicg", "shekharchalwadigrepo-hub" ], "_indexurl": "https://shekharchalwadigrepo-hub.r-universe.dev/openstudyval", "_binaries": [ { "r": "4.7.0", "os": "linux", "version": "0.1.1", "date": "2026-10-21T21:10:25.000Z", "distro": "resolute", "commit": "3a9f2dd8e3a8b0aa19efd880ba6b845a7876cbc4", "fileid": "https://r2.ropensci.org/a431f4b49948a880a761cd6b4ff11dcdf1b55935855d6c5c6986b40846726b0a", "status": "success", "check": "OK", "buildurl": "https://github.com/r-universe/cran/actions/runs/39675206106" }, { "r": "4.6.1", "os": "linux", "version": "0.1.1", "date": "2026-10-21T21:11:25.000Z", "distro": "resolute", "commit": "3a9f2dd8e3a8b0aa19efd880ba6b845a7876cbc4", "fileid": "https://r2.ropensci.org/0c236fae58bdcd091d7cf0501914ee6f39381f965843dec137636596208c3b3f", "status": "success", "check": "OK", "buildurl": "https://github.com/r-universe/cran/actions/runs/39675206106" }, { "r": "4.6.0", "os": "wasm", "version": "0.1.1", "date": "2026-10-21T21:10:00.000Z", "commit": "3a9f2dd8e3a8b0aa19efd880ba6b845a7876cbc4", "fileid": "https://r2.ropensci.org/2c2a2114fa91db79e5a49515ac2e341a8f5d8f117e0cbf492203f8f50431bdf2", "status": "success", "buildurl": "https://github.com/r-universe/cran/actions/runs/39675206106" }, { "r": "4.7.0", "os": "win", "version": "0.1.1", "date": "2026-10-21T21:09:30.000Z", "commit": "3a9f2dd8e3a8b0aa19efd880ba6b845a7876cbc4", "fileid": "https://r2.ropensci.org/65c8f41dcc27af0483c3bb23c98f636464bd48798ba87ee68125ed7f036f92ce", "status": "success", "check": "OK", "buildurl": "https://github.com/r-universe/cran/actions/runs/39675206106" }, { "r": "4.6.1", "os": "win", "version": "0.1.1", "date": "2026-10-21T21:09:30.000Z", "commit": "3a9f2dd8e3a8b0aa19efd880ba6b845a7876cbc4", "fileid": "https://r2.ropensci.org/836e251020b5a24fc8d1259f323b5cc19e93f9819dd9ee2725d8a43ff41758aa", "status": "success", "check": "OK", "buildurl": "https://github.com/r-universe/cran/actions/runs/39675206106" } ] }