SDTM model variable metadata — model

One row per variable of the CDISC SDTM model, at every version: 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 2.0, and 2.1. Built from CDISC Library CSV exports not redistributed with this package (see ig_sources); only variable metadata is carried, not the model's descriptions, definitions, notes, or examples. Retrieve it with get_ig("SDTM").

Usage

model_sdtm

Format

A data frame with columns:

standard: Always "SDTM".
version: Model version, e.g. "2.1".
class: Observation class or dataset class, e.g. "Findings", "Trial Design".
dataset: Dataset name, or NA for class-level variables.
order: Position within the class/dataset, as published.
variable: Variable name, e.g. "--TESTCD".
label: Variable label. "--TESTCD" is published at 46 characters in model versions 1.2 to 1.6.
type: "Char" or "Num".
role: CDISC variable role.
described_value_domain: A described value domain, e.g. "ISO 8601"; sparse before version 2.0.
variables_qualified: The variable(s) this one qualifies.
usage_restrictions: Usage restrictions on the variable; version 2.0 and later, NA before.
variable_code: The variable's NCI C-code; version 2.0 and later, NA before.

Source

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

Details

A (standard, version, class, dataset, variable) is unique. dataset is NA for the general-observation-class variables (Events, Findings, ...), which are defined once per class with a -- prefix, and set for the datasets the model defines outright (e.g. "DM").