{ "_id": "6a156d60acfb0bcc41d64382", "Package": "sdtmval", "Title": "Validate SDTM Domains", "Version": "0.4.1", "Authors@R": "person(\"Stephen\", \"Knapp\",\nemail = \"stephen@knappconsultingllc.com\",\nrole = c(\"aut\", \"cre\", \"cph\"),\ncomment = c(ORCID = \"0000-0002-5101-4555\"))", "Description": "Provides a set of tools to assist statistical programmers\nin validating Study Data Tabulation Model (SDTM) domain data\nsets. Statistical programmers are required to validate that a\nSDTM data set domain has been programmed correctly, per the\nSDTM Implementation Guide (SDTMIG) by 'CDISC'\n(), study\nspecification, and study protocol using a process called double\nprogramming. Double programming involves two different\nprogrammers independently converting the raw electronic data\ncut (EDC) data into a SDTM domain data table and comparing\ntheir results to ensure accurate standardization of the data.\nOne of these attempts is termed 'production' and the other\n'validation'. Generally, production runs are the official\nprograms for submittals and these are written in 'SAS'.\nValidation runs can be programmed in another language, in this\ncase 'R'.", "License": "MIT + file LICENSE", "Encoding": "UTF-8", "Roxygen": "list(markdown = TRUE)", "RoxygenNote": "7.2.3", "URL": "https://github.com/skgithub14/sdtmval,\nhttps://skgithub14.github.io/sdtmval/", "BugReports": "https://github.com/skgithub14/sdtmval/issues", "Config/testthat/edition": "3", "LazyData": "true", "VignetteBuilder": "knitr", "Config/pak/sysreqs": "make libicu-dev libx11-dev zlib1g-dev", "Repository": "https://skgithub14.r-universe.dev", "Date/Publication": "2023-10-20 16:10:49 UTC", "RemoteUrl": "https://github.com/skgithub14/sdtmval", "RemoteRef": "HEAD", "RemoteSha": "271b1b94d0517ed67b4a5aaa0a1cb6eb3cb3835a", "NeedsCompilation": "no", "Packaged": { "Date": "2026-05-26 09:49:13 UTC", "User": "root" }, "Author": "Stephen Knapp [aut, cre, cph] (ORCID:\n)", "Maintainer": "Stephen Knapp ", 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"spec_codelists", "class": [ "tbl_df", "tbl", "data.frame" ], "fields": [ "ID", "Term", "Decoded Value" ], "rows": 3, "table": true, "tojson": true }, { "name": "spec_datasets", "title": "Example 'Datasets' tab from a SDTM specification .xlsx file", "object": "spec_datasets", "class": [ "tbl_df", "tbl", "data.frame" ], "fields": [ "Dataset", "Description", "Structure", "Key Variables" ], "rows": 1, "table": true, "tojson": true }, { "name": "spec_XX", "title": "Example domain specific tab from a SDTM specification .xlsx file", "object": "spec_XX", "class": [ "tbl_df", "tbl", "data.frame" ], "fields": [ "Order", "Dataset", "Variable", "Label", "Data Type", "Length" ], "rows": 12, "table": true, "tojson": true }, { "name": "vd", "title": "Example EDC data for form/table 'VD'", "object": "vd", "class": [ "data.frame" ], "fields": [ "USUBJID", "VISIT", "VISITDTC" ], "rows": 8, "table": true, "tojson": true }, { "name": "xx_no_meta_data", "title": "Example SDTM domain table XX without meta data", "object": "xx_no_meta_data", "class": [ "tbl_df", "tbl", "data.frame" ], "fields": [ "STUDYID", "USUBJID", "XXSEQ", "XXTESTCD", "XXTEST", "XXORRES", "XXBLFL", "VISIT", "EPOCH", "XXDTC", "XXDY" ], "rows": 10, "table": true, "tojson": true } ], "_help": [ { "page": "assign_meta_data", "title": "Assign meta data to columns in a SDTM table based on specification file", "topics": [ "assign_meta_data" ] }, { "page": "assign_SEQ", "title": "Assign SEQ numbers for a SDTM data set", "topics": [ "assign_SEQ" ] }, { "page": "calc_DY", "title": "Calculate a DY variable (day of study)", "topics": [ "calc_DY" ] }, { "page": "convert_to_script", "title": "Convert SDTM QC code from a .Rmd file to .R script", "topics": [ "convert_to_script" ] }, { "page": "create_BLFL", "title": "Create a BLFL column", "topics": [ "create_BLFL" ] }, { "page": "create_EPOCH", "title": "Create the EPOCH variable", "topics": [ "create_EPOCH" ] }, { "page": "create_STAT", "title": "Assign STAT 'NOT DONE' status", "topics": [ "create_STAT" ] }, { "page": "dm", "title": "Example SDTM Domain 'DM'", "topics": [ "dm" ] }, { "page": "edc_xx", "title": "Example EDC data for form/table 'XX'", "topics": [ "edc_xx" ] }, { "page": "format_chars_and_dates", "title": "Format date and character columns for SDTM tables", "topics": [ "format_chars_and_dates" ] }, { "page": "get_codelist", "title": "Read in the code list from the specification for a specific domain", "topics": [ "get_codelist" ] }, { "page": "get_data_spec", "title": "Read in the variable specification sheet for a SDTM data set", "topics": [ "get_data_spec" ] }, { "page": "get_key_vars", "title": "Read in the key variables for a SDTM domain", "topics": [ "get_key_vars" ] }, { "page": "impute_pdates", "title": "Impute start or end dates", "topics": [ "impute_pdates" ] }, { "page": "read_edc_tbls", "title": "Import EDC data tables", "topics": [ "read_edc_tbls" ] }, { "page": "read_sdtm_tbls", "title": "Import SDTM data tables", "topics": [ 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