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:

Dataset	Standards	Standard versions	Rows
ig_sdtm	SDTMIG 3.1.2 to 3.4, SDTMIG-AP, SDTMIG-MD, SENDIG 3.0 to 3.1.1, SENDIG-AR, SENDIG-DART, SENDIG-GeneTox	14	10,064
model_sdtm	SDTM model 1.2 to 2.1	9	3,604
ig_adam	ADaMIG 1.0 to 1.3, ADaMIG-MD, ADaMIG-NCA, ADaM-ADAE, ADaM-BDS-TTE, ADaM-OCCDS, ADaM-popPK	11	1,804
cdash_model	CDASH model 1.0 to 1.3	4	1,138
ig_cdash	CDASHIG 1.1, 2.0 to 2.3	5	4,483
qrs_supplement	AIMS, APACHE_II, ATLAS, CGI, HAM-A, KFSS, KPS_SCALE, PGI, SIX_MINUTE_WALK	9	75

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:

Decision	Rationale
Zero runtime dependencies	Easier deployment in locked/air-gapped environments; CRAN friendly
Validity-date CT storage	Compact representation of all historical releases without row duplication
No CDISC Library API key required	CT, schemas, and stylesheets are public domain / open-source licensed; the IG, model, CDASH, and QRS metadata is transcribed from CDISC Library CSV exports downloaded under CDISC's terms and not redistributed (see Data sources)
Per-release RDS cache in data-raw/raw/	Fast incremental rebuilds; preserves full audit trail

Data sources

Data	Source	License
SDTM CT	NCI EVS FTP	Public domain
ADaM CT	NCI EVS FTP	Public domain
SDTM model, SDTMIG, SENDIG, ADaMIG, and related guides: variable metadata	34 CDISC Library CSV exports, downloaded under CDISC's terms and not redistributed; only variable metadata is transcribed (not the CDISC Notes, Description, Definition, Notes, or Examples text); see data-raw/README.md	CDISC terms and conditions
CDASH model and CDASHIG variable metadata	9 CDISC Library CSV exports, as above; the collection wording (question text, prompt) is carried, the definitions, mapping and CRF completion instructions, and implementation notes are not	CDISC terms and conditions
QRS supplement item metadata	9 CDISC Library CSV exports, as above; the --TEST and --TESTCD names and codes are carried, the item text is not	CDISC terms and conditions
Define-XML 2.1 schema	cdisc-org/DataExchange-RWD-Lineage	Apache 2.0
Define-XML 2.0 schema	dbosak01/defineR	MIT
XSLT stylesheets	cdisc-org/data-definition-engine / dbosak01/defineR	Apache 2.0 / MIT

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