SDTM Supplemental Qualifiers (SUPP--)

Description

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

supp--.xpt, Supplemental Qualifiers for [domain name] — Relationship. One record per supplemental qualifier per related parent domain record(s), Tabulation.

Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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	Study identifier of the parent record(s).	Req
RDOMAIN	Related Domain Abbreviation	Char	(DOMAIN)	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).	Req
IDVAR	Identifying Variable	Char		Identifier	Identifying variable in the dataset that identifies the related record(s). Examples: --SEQ, --GRPID.	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.	Req
QLABEL	Qualifier Variable Label	Char		Synonym Qualifier	This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the applicant's original 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	Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data.	Req
QEVAL	Evaluator	Char		Record Qualifier	Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include "ADJUDICATION COMMITTEE", "STATISTICIAN", "DATABASE ADMINISTRATOR", "CLINICAL COORDINATOR", etc.	Exp

Assumptions

There are no additional SUPPQUAL-specific assumptions; all are included in Section 2.8.5.3, Relating NSVs and Attributions to a Domain.

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SDTM Supplemental Qualifiers (SUPP--)