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Description

A relationship dataset used to describe nonstandard variables and their association to parent records in general-observation class datasets.


Specification

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable Name

Variable Label

Type

Controlled Terms, Codelist, or Format

Role

CDISC Notes

Core

STUDYID

Study Identifier

Char


Identifier

Unique study identifier of the parent record(s).

Req

RDOMAIN

Related Domain Abbreviation

Char


Identifier

Two-character abbreviation for the domain of the parent record(s).

Req

USUBJID

Unique Subject Identifier

Char


Identifier

Unique subject identifier of the parent record(s). Either USUBJID or POOLID must be populated.

Exp

POOLID

Pool Identifier

Char


Identifier

Pool identifier of the Parent record(s).. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated.

Perm

IDVAR

Identifying Variable

Char


Identifier

Identifying variable in the dataset that identifies the related record(s). Examples: BWSEQ, CLGRPID.

Exp

IDVARVAL

Identifying Variable Value

Char


Identifier

Value of identifying variable of the parent record(s).

Exp

QNAM

Qualifier Variable Name

Char


Topic

The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters nor can it start with a number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the applicant's operational dataset. The value in QNAM may not be the same as any variable name defined in another domain or the SDTM. The QNAM should uniquely correspond to a QLABEL within a single domain.

Req

QLABEL

Qualifier Variable Label

Char


Synonym Qualifier

This is the long name or label associated with QNAM. The value in QLABEL should be in title case and cannot be longer than 40 characters. This will often be the column label in the sponsor's operational dataset.

Req

QVAL

Data Value

Char


Result Qualifier

Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in SUPP-- with a null value for QVAL.

Req

QORIG

Origin

Char


Record Qualifier

QORIG is used to indicate the origin of the data. Possible values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE.

Perm

QEVAL

Evaluator

Char


Record Qualifier

Used only for results that are subjective (i.e., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include PATHOLOGIST or VETERINARIAN, etc.

Perm


Assumptions

include


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