get_sdtm_metadata: SDTM Metadata

In clinCompare: Dataset Comparison with 'CDISC' Validation for Clinical Trial Data

SDTM Metadata

Description

Returns metadata for SDTM domains following CDISC standards. Provides information about required, expected, and permissible variables for each SDTM domain.

Usage

get_sdtm_metadata(version = "3.4")

Arguments

version

Character string specifying the SDTM IG version. Supported values: "3.4" (default, based on SDTM v2.0), "3.3" (based on SDTM v1.7). Version "3.3" excludes 7 domains introduced in v3.4 (GF, CP, BE, BS, SM, TD, TM). Within a domain, the variable lists are the same across versions – this parameter only controls which domains are available, not per-variable version differences.

Details

Variable definitions are based on the published CDISC SDTM Implementation Guide. The canonical machine-readable source is the CDISC Library API (https://www.cdisc.org/cdisc-library), which requires CDISC membership. The metadata shipped with clinCompare is hand-curated from the published IG specifications and should be cross-referenced with the official CDISC Library for regulatory submissions.

Value

A named list where keys are SDTM domain codes and values are data.frames with columns:

variable

Variable name (character)

label

Variable label/description (character)

type

Data type: "Char" for character or "Num" for numeric

core

Importance level: "Req" (Required), "Exp" (Expected), or "Perm" (Permissible)

clinCompare documentation built on Feb. 19, 2026, 1:07 a.m.