Versioned CDISC Standards Reference Data

Provides versioned reference data for the standards of the Clinical Data Interchange Standards Consortium (CDISC) < https://www.cdisc.org/standards>: the CDISC Controlled Terminology (CT) for the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM); variable metadata for the SDTM model and for the families of the SDTM Implementation Guide (SDTMIG), the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG), and the ADaM Implementation Guide (ADaMIG); the Clinical Data Acquisition Standards Harmonization (CDASH) model and implementation guide; the Questionnaires, Ratings, and Scales (QRS) supplements; and the Define-XML schemas, written in the Extensible Markup Language (XML) Schema Definition (XSD) language, with Extensible Stylesheet Language Transformations (XSLT) stylesheets for them. A validity-date design stores every historical CT version compactly, without duplicating rows. Intended as a shared data dependency for pharmaverse-aligned packages < https://pharmaverse.org>.

cdiscdata

cdiscdata provides versioned CDISC reference data as a standard R package, with zero runtime dependencies. It bundles:

• Controlled Terminology (CT): all historical SDTM and ADaM CT releases from the NCI EVS FTP site, stored compactly using a validity-date design (one row per term-state, not one copy per release). Current as of the 2026-09-25 NCI release.
• Implementation-guide, model, CDASH, and QRS variable metadata: the variables of 34 SDTM-, SEND-, and ADaM-side guides (the SDTM model; SDTMIG 3.1.2 to 3.4, -AP, -MD; SENDIG 3.0 to 3.1.1, -AR, -DART, -GeneTox; ADaMIG 1.0 to 1.3, -MD, -NCA, ADaM-ADAE, -BDS-TTE, -OCCDS, -popPK), the CDASH model and CDASHIG, and the items of nine QRS instrument supplements, at every version. See get_ig(), get_cdash(), and build_domain_spec().
• Define-XML XSD schemas: for validating define.xml files (versions 2.0 and 2.1).
• XSLT stylesheets: for rendering define.xml as HTML (versions 2.0 and 2.1).

CT, Define-XML schemas, and XSLT stylesheets are sourced exclusively from publicly available, license-free sources, with no CDISC Library API key needed. The IG, model, CDASH, and QRS metadata is transcribed from CDISC Library CSV exports that were downloaded under CDISC's own terms and conditions. Those exports are not in this repository and are not redistributed; only variable metadata is carried, not the guides' prose. See Data sources and data-raw/README.md.

Installation

Install the development version from GitHub:

# install.packages("pak")
pak::pak("humanpred/cdiscdata")

Usage

Discover what is available

library(cdiscdata)

# List all bundled datasets with version counts and latest release dates
list_datasets()

# See package-level version metadata
cdiscdata_versions()

Controlled Terminology

# Latest SDTM CT (all codelists and terms as a data frame)
ct <- get_ct("sdtm")
nrow(ct)
head(ct[, c("codelist_code", "codelist_name", "term", "decoded_value")])

# All available CT release dates, most recent first
versions <- available_ct_versions("sdtm")
head(versions)

# CT as it existed at a specific historical release
ct_prev <- get_ct("sdtm", version = versions[[2]])

# ADaM CT works the same way
ct_adam <- get_ct("adam")

The validity-date design means historical data is stored without duplication: each row carries a valid_from date and an valid_to date (NA = still current). get_ct() reconstructs the state of any release on the fly.

Implementation-guide variable metadata

# The newest SDTMIG (3.4), every domain
get_ig()

# One standard, one version, one domain
get_ig("SDTMIG", version = "3.3", domain = "PP")
get_ig("SENDIG", domain = "PP")

# The SDTM model, and the ADaM guides and their extensions
get_ig("SDTM", version = "2.1", domain = "Findings")
get_ig("ADaMIG", domain = "BDS")
get_ig("ADaMIG-NCA")

# The CDASH model and implementation guide
get_cdash()
get_cdash("CDASHIG", version = "2.1", domain = "LB")

# A ready-to-use variable spec (name, label, type, core, order, source,
# codelist id) for PP, SUPPPP, or ADPP, joined to CT for codelist ids
build_domain_spec("PP")
build_domain_spec("SUPPPP")
build_domain_spec("ADPP")                       # ADaMIG BDS + ADSL
build_domain_spec("ADPP", extension = "NCA")    # ... + ADaMIG-NCA

Every standard and version bundled, and the export each was built from:

ig_sources lists each export, its parsed standard and version, its row count, and its checksum.

Define-XML schemas and stylesheets

# File paths to the bundled XSD and XSLT assets
schema_path("2.1")       # path to the Define-XML 2.1 XSD directory
stylesheet_path("2.1")   # path to the Define-XML 2.1 XSLT file

# Validate a define.xml with xml2 (example)
library(xml2)
doc    <- read_xml("path/to/define.xml")
schema <- read_xml(file.path(schema_path("2.1"), "define2-1-0.xsd"))
xml_validate(doc, schema)

Unified access via get_dataset()

# get_dataset() is a single entry point for all bundled assets
get_dataset("ct_sdtm")                          # latest SDTM CT
get_dataset("ct_adam", version = "2024-03-29")  # historical ADaM CT
get_dataset("ig_adam", version = "1.3")         # IG, model, CDASH, QRS tables
get_dataset("qrs_supplement")
get_dataset("define_xml_schema",     version = "2.1")
get_dataset("define_xml_stylesheet", version = "2.0")

Design

cdiscdata is intended as a shared data dependency for pharmaverse-aligned packages (e.g. cdisclib, defineauto). Key design decisions:

Data sources

Related packages

• cdiscapi (forthcoming): CDISC Library API access (requires API key) for metadata not available from public sources or from the exports bundled here - e.g. guides and versions newer than those get_ig() and get_cdash() cover.
• cdisclib: Core utilities built on top of cdiscdata.
• defineauto: Automated Define-XML generation.

License

MIT + file LICENSE