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First CRAN submission: the maintainer email address is corrected,
the copyright holders of the bundled Define-XML schema files (CDISC, MIT
License) and stylesheets (Lex Jansen, MIT License) are stated in
Authors@R and inst/COPYRIGHTS (the README had
described them as Apache-licensed), and a spelling word list is
added.
Resubmission: the Description explains every acronym and links
the CDISC standards, and the attach test no longer installs the package
(it runs against the installed copy under R CMD check and
skips from a source tree), so pkgbuild leaves Suggests.
inst/COPYRIGHTS lists the source, copyright holder,
and license of every bundled file and data table, including the
standards metadata tables added in this version.
ig_sdtm, ig_adam, and the new
model_sdtm are rebuilt from 34 CDISC Library CSV exports
and carry every standard and version in them, replacing every row
transcribed from the Rsdtm package:
| Table | Standards | Standard versions | Rows |
|---|---|---|---|
model_sdtm |
SDTM model | 9 | 3,604 |
ig_sdtm |
SDTMIG, SDTMIG-AP, SDTMIG-MD, SENDIG, SENDIG-AR, SENDIG-DART, SENDIG-GeneTox | 14 | 10,064 |
ig_adam |
ADaMIG, ADaMIG-MD, ADaMIG-NCA, ADaM-ADAE, ADaM-BDS-TTE, ADaM-OCCDS, ADaM-popPK | 11 | 1,804 |
Only variable metadata is carried. The guides’ prose (CDISC Notes, Description, Definition, Notes, Examples) is not in the package data.
Breaking: new columns. ig_sdtm is
now standard, version, class,
domain, order, variable,
label, type, role,
core, codelist_code,
codelist_submission_values,
described_value_domain, value_list.
ig_adam is standard, version,
structure, variable_set, order,
variable, label, type,
core, codelist_code,
codelist_submission_values,
described_value_domain, value_list.
model_sdtm is standard, version,
class, dataset, order,
variable, label, type,
role, described_value_domain,
variables_qualified, usage_restrictions,
variable_code. The old source (now
standard), dataset and category
(ADaM; now structure and variable_set),
codelist (now codelist_code, a C-code rather
than a submission value), length, and notes
columns are gone. The SDTM model moved out of ig_sdtm into
model_sdtm.
ig_sources lists the exports each table was built
from: file name, the export’s version string, the parsed standard and
version, the dataset it was loaded into, its row count, and its MD5
checksum.
cdash_model (CDASH model 1.0 to 1.3, 1,138 rows),
ig_cdash (CDASHIG 1.1 and 2.0 to 2.3, 4,483 rows), and
qrs_supplement (75 items of nine questionnaire,
rating-scale, and functional-test supplements, 9 instrument versions),
from 18 more CDISC Library exports. The CDASH tables carry the
collection wording (question_text, prompt) and
the SDTM target of each field, but not the definitions, CRF completion
instructions, mapping instructions, or implementation notes.
qrs_supplement carries the
--TEST/--TESTCD names and codes of each item
but not the item text. The QRS exports have no version column, so the
instrument and version are read from the file name.get_cdash(standard, version, domain) for the CDASH
tables, with the same conventions as get_ig(). It is a
separate function because the CDASH tables describe data collection, not
a dataset’s structure, and so have different columns. The QRS
supplements are reached with
get_dataset("qrs_supplement").get_ig(standard, version, domain).
standard now names one of 15 standards
("SDTM", "SDTMIG", "SDTMIG-AP",
"SDTMIG-MD", "SENDIG",
"SENDIG-AR", "SENDIG-DART",
"SENDIG-GeneTox", "ADaMIG",
"ADaMIG-MD", "ADaMIG-NCA",
"ADaM-ADAE", "ADaM-BDS-TTE",
"ADaM-OCCDS", "ADaM-popPK"). The default is
"SDTMIG", and a NULL version now
returns that standard’s newest version (compared numerically) where it
used to return every version. The lower-case "sdtm" and
"adam" are kept as aliases for "SDTMIG" and
"ADaMIG"; capital "SDTM" is the model.
domain filters by domain (SDTMIG), class or dataset (SDTM
model), or structure (ADaM, where "BDS" and
"ADSL" are accepted). An unknown standard, version, or
domain is a classed error
(cdiscdata_error_ig_standard_unavailable,
cdiscdata_error_ig_version_unavailable,
cdiscdata_error_ig_domain_unavailable) listing what is
available.get_dataset("ig_sdtm") and
get_dataset("ig_adam"). They silently returned
NULL. They now return the table, whole or restricted to the
rows of one version string, and get_dataset("model_sdtm"),
get_dataset("cdash_model"),
get_dataset("ig_cdash") and
get_dataset("qrs_supplement") work the same way.
list_datasets() reports the new tables with types
"Model", "CDASH", and "QRS", and
counts versions per standard.build_domain_spec() takes a standard (any
SDTM-side standard that defines the domain, e.g. "SENDIG"
for PP) and an extension for ADPP:
"ADaMIG-NCA" (or "NCA"),
"ADaM-popPK", or "ADaM-BDS-TTE" is unioned
onto the BDS variables, as adsl = TRUE unions ADSL, with
extension_version to pick its version. Unlike the ADSL and
PP unions, the extension keeps its own Core designations: a variable the
BDS already defines takes the extension’s Core (DOSEA,
DOSEU, and AVISIT become required in
ADaMIG-NCA) and is marked with the extension’s name in
source. Existing calls keep working.build_domain_spec("ADPP", extension = "NCA") has 388
variables. sdtm_domain = "PP" adds 24 variables (22 with
sdtmig_version = "3.3").length column is kept but is always
NA: the exports carry no length, which is a sponsor choice.
codelist_id takes the first C-code of an IG codelist list,
kept only when that codelist is in the CT release used.test-ig_integrity.R and
test-cdash_integrity.R: every export is loaded exactly once
and with as many rows as its file has; every row is unique on its key;
no name or label is NA or contains a newline; no text field
has stray whitespace; no value is long enough to be prose;
type and core hold only published values; and
no CSV is tracked under data-raw. The version-string parser
is tested on all 43 version strings and on the nine QRS file names.helper-ig-exceptions.R: 22 in the SDTM and ADaM tables
(SDTMIG 3.2 and SDTMIG-MD 1.0 long forms that later versions abbreviate,
the SDTM model --TESTCD before 1.7, and ADaMIG
PBCHGCyN), 6 in the CDASH model, and 71 in CDASHIG 2.0.
Both directions are checked, so a new over-length label fails and so
does an exception that is no longer true. CDASHIG 1.1 publishes no
variable labels at all (NA). Five SDTMIG and SDTMIG-MD rows
have no type or core in the guide and are
listed the same way. Shortening a label to fit an XPT file is for
whoever writes the dataset, not for this package.data-raw/utils_ig.R is tested on synthetic exports
written to a temporary directory, including that no prose column of any
export layout reaches the data.EPOCH, TAETORD and PPDY first
appear in 3.3, and PPANMETH and PPTPTREF in
3.4. PPDTC, not PPPDTC, is the published name,
and nca.reporter’s PTAETORD, PPPDTC and
PPPDY are not published SDTMIG variables.PPSTRESC is published as “Character
Result/Finding in Standard Format” (43 characters; 3.3 abbreviates it).
It is now carried as published and is one of the exceptions above, where
an earlier development version had abbreviated it.CDISC_SOURCES_DIR (default ../cdisc-sources)
by data-raw/build_ig.R, which stops with a message listing
every expected file if any is missing and refuses a QRS supplement it
does not list. data-raw/README.md says how to obtain them.
The Rsdtm copies in data-raw/ig_source/ and the scripts
that read them are removed.get_ig() and
build_domain_spec() raise is now classed
(e.g. cdiscdata_error_ig_version_unavailable,
cdiscdata_error_no_ig_variables,
cdiscdata_warning_adsl_ignored), so they can be caught or
asserted on by class rather than by matching message text. Implemented
with a small internal .cdiscdata_abort()/
.cdiscdata_warn() helper rather than a new dependency
(e.g. rlang), to keep the package’s zero-runtime-dependency design.build_domain_spec() is now at 100% line coverage; two
defensive checks (an SDTMIG/ADaMIG version with no rows for the
requested domain/dataset - not reachable via the public API with the
currently bundled ig_sdtm/ ig_adam, since
every version there has PP/SUPPQUAL/BDS rows) are exercised directly via
mocking get_ig().data-raw/utils_nci.R) that had
silently left codelist_name NA for every row
of ct_sdtm/ct_adam for every NCI release from
2012 onward (codelist_name and codelist_code
are used to look up a codelist by name, e.g. by
get_ig()/build_domain_spec(), so this
previously made resolving PKPARMCD/PKPARM/PKUNIT - or any other codelist
by name - unreliable). The header-row detection this relied on assumed
the NCI source file repeats a codelist’s own C-code in both its “Code”
and “Codelist Code” columns; from 2012 on, NCI instead leaves “Codelist
Code” blank on that row, which the previous logic never matched. All
bundled historical releases were re-parsed from scratch with the fix
(re-downloading the ~110 archived releases involved, now cached as raw
text going forward so a future parser fix would not need to). A handful
of older (2007-2010, plus one 2017) archival releases have further,
rarer source-data quirks this could not fully resolve; the
current release is verified clean, and the historical gap is
bounded by tests/testthat/test-data_integrity.R rather than
silently tolerated.list_archive_dates(), which had been silently
returning zero dates: NCI rebuilt evs.nci.nih.gov as a JavaScript
single-page app at some point in 2024-2025, so the Archive/ directory
URL this scraped for file names now serves that app’s empty HTML shell
instead of a plain listing. It now calls the JSON API the app itself
uses (GET /ftp1/folder?folder=<path>) instead; see
the comment above list_archive_dates() in
data-raw/utils_nci.R for that API’s one limitation (no
working pagination past 1000 entries) and why it does not affect finding
every release date in practice.
fetch_current_release_date() (previously reading NCI’s
Publication Date Stamp file, which changed format at least twice - a
bare date, then “SDTM Terminology YYYY-MM-DD”, then, as of 2026, a small
table - and 403’d from GitHub Actions in between) was replaced with a
derivation from this same, now-working archive listing
(origin/main PR “fix/nci-stamp-403-fallback”, merged into
this branch).available_ct_versions()
- SDTM CT appeared to be missing the 2024-06, 2024-12, 2025-06, 2025-12,
and 2026-06 quarterly releases. Verified directly against NCI’s own file
listing (not assumed): none of these five releases exist for either SDTM
or ADaM - NCI shifted SDTM CT from quarterly to semi-annual
(March/September) releases starting in 2024, and ADaM CT has never been
reliably quarterly (gaps of 266-448 days recur from 2017 on, long before
2024). There was nothing to backfill. Added
tests/testthat/test-data_integrity.R gap tests calibrated
to each type’s actual verified history (200 days for SDTM, 500 days for
ADaM; not a single ~120-day bound, which would flag the genuine 2024-on
semi-annual gaps as failures) plus a freshness check, so a release that
is actually skipped or a fetch workflow that silently stops
running would still fail loudly.PKPARMCD (C85839), PKPARM
(C85493), and PKUNIT (C85494) are present in the 2026-09-25
release and returned by get_ct("sdtm").get_ct(), get_dataset(),
list_datasets(), cdiscdata_versions(), and
available_ct_versions() to work via
cdiscdata:: alone, without library(cdiscdata)
first. Lazy-loaded package data (ct_sdtm,
ct_adam, ig_sdtm, ig_adam,
datasets_catalogue) is only wired into the search path when
the package is attached; loading just the namespace (as
:: does) left an unqualified reference to that data
unresolved, even from inside the package’s own functions -
e.g. cdiscdata::get_ct("sdtm") without a prior
library() call errored with
object 'datasets_catalogue' not found. Fixed via an
internal .pkg_data() helper that loads a dataset explicitly
with utils::data(), independent of attach state. Verified
by a dedicated test (tests/testthat/test-attach.R) that
builds and installs the package into a fresh library and calls it via
callr::r() in a brand-new subprocess with no
library() call.ig_sdtm: SDTM Model Findings
general-observation-class variables (versions 1.4-1.7), plus the SDTMIG
PP domain and the generic SUPP– qualifier structure (version 3.2 only -
see data-raw/ig_source/README.md for why no newer SDTMIG
version’s PP/SUPP– tables were available to source).ig_adam: ADaMIG ADSL (subject-level) and BDS
(Basic Data Structure, used by ADPP) variable tables, for versions 1.0,
1.1, and 1.2.get_ig(standard, version), mirroring
get_ct().build_domain_spec(domain, ig_version, ct_version, adsl),
returning a ready-to-use variable spec (name, label, type, length, core,
order, source, codelist id) for "PP", "SUPPPP"
(via the generic SUPP– structure), or "ADPP" (via the
generic BDS structure, joined against CT for codelist ids). For
"ADPP", adsl = TRUE (the default) also unions
in the ADaMIG ADSL variables - a real ADPP carries ADSL’s subject-level
variables alongside its own BDS variables - marked
source = "ADSL" and core = "Perm" (ADSL’s own
Core reflects requirements for ADSL itself, not for merging a variable
into ADPP, which is always optional); a variable defined by both tables
(e.g. STUDYID, USUBJID) keeps its BDS version
rather than being duplicated. adsl = FALSE returns the BDS
variables alone, as before. Neither table carries PP’s own variables
(PPTESTCD and the rest) forward into ADPP; that remains a
downstream derivation choice, not IG metadata this function
sources.get_ig()/ig_sdtm’s SDTMIG-3.2-only
coverage of the PP domain and SUPP– structure is now called out
explicitly in get_ig()’s documentation, including the
specific known gaps versus a newer SDTMIG (PPANMETH,
EPOCH, PTAETORD not yet added; SDTMIG 3.2
still has PPDTC, not the later PPPDTC
rename).data-raw/ig_source/README.md. This supersedes the package’s
original plan to leave all IG metadata to a separate
cdiscapi package; the README has been updated
accordingly.cdiscdata.get_ct(), get_dataset(),
available_ct_versions(), schema_path(),
stylesheet_path(), list_datasets(),
cdiscdata_versions().These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.