"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 4.1.3 for POOLDEF and 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."
