SDTMVariableSpec

The specification of one variable in an SDTM domain template.

Usage

SDTMVariableSpec(
    name,
    label,
    dtype,
    role,
    required=False,
    max_length=None,
    controlled_term=None,
    core="Perm",
)

An SDTMDomainTemplate holds an SDTMVariableSpec for each variable of its domain, in its variables list. The specification gives what the SDTM Implementation Guide says about the variable: its label, its type, its role in the domain, its core designation, and the controlled terminology for its values. validate_sdtm() uses required, dtype, max_length and role to decide which checks to make.

Parameters

name: str: The variable name, such as "STUDYID" or "AESTDTC".
label: str: The variable label, such as "Study Identifier".
dtype: str: The SDTM data type: "Char" for character variables or "Num" for numeric ones.
role: str: The variable’s SDTM role. The templates use "Identifier" (variables that identify the study, subject, domain or record), "Topic" (the focus of the observation, such as AETERM), "Qualifier" (variables that describe the observation) and "Timing" (dates, times and study days).
required: bool = False: Whether the variable is required: it must be in the dataset and can’t be null. In the templates, this is True exactly when core is "Req". The default is False.
max_length: int | None = None: The maximum length of the values of a character variable. The default is None (no maximum, as for numeric variables).
controlled_term: str | None = None: The name of the controlled terminology codelist for the variable’s values, such as "SEX" or "NY". The default is None.
core: str = "Perm": The core designation: "Req" (required), "Exp" (expected: in the dataset, but values may be null) or "Perm" (permissible: included when there is data for it). The default is "Perm".

Examples

Specifications are usually taken from a template. Here is the one for AESER in the Adverse Events (AE) template:

import pointblank as pb

aeser = pb.get_sdtm_domain("AE").get_variable("AESER")

aeser

SDTMVariableSpec(name='AESER', label='Serious Event', dtype='Char', role='Qualifier', required=False, max_length=2, controlled_term='NY', core='Exp')

AESER (whether the adverse event was serious) is an expected character variable of at most two characters, with values from the NY (No Yes Response) codelist.

Parameters

Examples

See Also