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One row per variable of every domain of seven implementation-guide standards, at every version: SDTMIG (3.1.2, 3.1.3, 3.2, 3.3, 3.4), SDTMIG-AP (1.0), SDTMIG-MD (1.0, 1.1), SENDIG (3.0, 3.1, 3.1.1), SENDIG-AR (1.0), SENDIG-DART (1.1), and SENDIG-GeneTox (1.0); 14 standard versions in all. Built from CDISC Library CSV exports that are not part of this package or repository (see ig_sources and data-raw/README.md); only variable metadata is carried, not the guides' prose. Use get_ig to retrieve a standard, and build_domain_spec to build a ready-to-use PP/SUPPPP/ADPP variable spec from it. The SDTM model itself is in model_sdtm.

Usage

ig_sdtm

Format

A data frame with columns:

standard

The standard, e.g. "SDTMIG" or "SENDIG-AR".

version

The standard's version, e.g. "3.4".

class

General observation class, e.g. "Findings".

domain

Domain, e.g. "PP", "LB", "SUPPQUAL".

order

Position within the domain, as published.

variable

Variable name, e.g. "PPTESTCD".

label

Variable label. At most 40 characters except for 22 labels the guides themselves publish longer (see the data-integrity tests).

type

"Char" or "Num".

role

CDISC variable role, e.g. "Topic".

core

Core designation ("Req", "Exp", "Perm", "Cond", or the published "Not used").

codelist_code

CDISC CT codelist C-code(s) the variable uses, as published; several are separated by "; " (e.g. PPORRESU lists PKUNIT and four normalised-unit codelists). NA when none.

codelist_submission_values

The codelist submission value(s), where the export gives them (the SEND guides do; the SDTMIG exports do not, so look the code up in get_ct).

described_value_domain

A described value domain such as "ISO 8601", where the variable has one rather than a codelist.

value_list

A fixed list of allowed values, e.g. the domain abbreviation for DOMAIN.

Source

CDISC Library CSV exports, downloaded under CDISC's terms and not redistributed; see data-raw/README.md.

Details

A (standard, version, domain, variable) is unique.