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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. See Section 3.2.2.1.
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.