"Variable
Name ",Variable Label ,Type ,Description
STUDYID ,Study Identifier ,Char ,Study Identifier of the parent record(s).
RDOMAIN ,"Related Domain
Abbreviation",Char ,Two-character abbreviation for the domain of the parent record(s).
USUBJID ,Unique Subject Identifier ,Char ,"Identifier used to uniquely identify a subject across all studies for all
applications or submissions involving the product."
APID ,"Associated Persons
Identifier",Char ,"Identifier for a single associated person, a group of associated persons, or
a pool of associated persons. If APID identifies a pool, POOLDEF
records must exist for each associated person. (See Section 5 for
Associated Persons data)"
POOLID ,Pool Identifier ,Char ,"Identifier used for pooling subjects to assign a single finding to multiple
subjects."
IDVAR ,Identifying Variable ,Char ,"Identifying variable in the parent dataset that identifies the related
record(s). Examples: --SEQ, --GRPID."
IDVARVAL ,Identifying Variable Value ,Char ,Value of identifying variable of the parent record(s).
QNAM ,Qualifier Variable Name ,Char ,"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”). QNAM cannot contain characters other than letters,
numbers, or underscores. This will often be the column name in the
sponsor’s operational dataset."
QLABEL ,Qualifier Variable Label ,Char ,"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 sponsor’s original dataset."
QVAL ,Data Value ,Char ,"Result of, response to, or value associated with QNAM. A value for this
column is required; no records can be in a SUPP-- dataset with a null
value for QVAL"
QORIG ,Origin ,Char ,"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.
Examples include CRF, ASSIGNED, or DERIVED."
QEVAL ,Evaluator ,Char ,"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."
