SEND 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 IDVAR, IDVARVAL, and QNAM value per subject per related domain, Tabulation.

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	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

Timing variables cannot be added to SUPPQUAL datasets.
Additional SUPPQUAL assumptions are included in Section 2.8.5.3, Relating NSVs and Attributions to a Domain.

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SEND Supplemental Qualifiers (SUPP--)