"Variable
Name ",Variable Label ,Type ,Description
STUDYID ,Study Identifier ,Char ,Unique identifier for a study.
DOMAIN ,"Domain
Abbreviation",Char ,"Two-character abbreviation for the domain most relevant to the observation. The
Domain abbreviation is also used as a prefix for variables to ensure uniqueness when
datasets are merged."
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 ,"An identifier used to identify a result from a group of subjects that is not assignable to a
specific subject."
SPDEVID ,"Sponsor Device
Identifier",Char ,Sponsor-defined identifier for a device.
FETUSID ,Fetus Identifier ,Char ,"Identifier used to identify a fetus from a maternal subject for prenatal evaluations.
FETUSID uniquely identifies a fetus within a subject. Not to be used with human
clinical trials."
FOCID ,"Focus of Study
Specific
Interest",Char ,"Identification of a focus of study-specific interest on or within a subject or specimen as
called out in the protocol for which a measurement, test, or examination was performed,
such as a drug application site, e.g., ""Injection site 1"", ""Biopsy site 1"", ""Treated site 1"",
or a more specific focus, e.g., ""OD"" (right eye) or ""Upper left quadrant of the back"". The
value in this variable should have inherent semantic meaning."
--SEQ ,"Sequence
Number",Num ,"Sequence number to ensure uniqueness of records within a dataset for a subject (or
within a parameter, in the case of the Trial Summary domain). May be any valid number
(including decimals) and does not have to start at 1."
--GRPID ,Group ID ,Char ,"Optional group identifier, used to link together a block of related records within a subject
in a domain. Also used to link together a block of related records in the Trial Summary
dataset (Section 3.4)."
--REFID ,Reference ID ,Char ,"Optional internal or external identifier such as lab specimen ID, or UUID for an ECG
waveform or a medical image."
--RECID ,"Invariant
Record
Identifier",Char ,"Identifier for a record that is unique within a domain for a study and that remains
invariant through subsequent versions of the dataset, even if the content of the record is
modified. When a record is deleted, this value must not be reused to identify another
record in either the current or future versions of the domain."
--SPID ,"Sponsor
Defined
Identifier",Char ,"Sponsor-defined identifier. Example: pre-printed line identifier on a Concomitant
Medications page."
--LNKID ,Link ID ,Char ,"Identifier used to link related records across domains. This may be a one-to-one or a one
to-many relationship. For Example: A single tumor may have multiple
measurements/assessments performed at each study visit."
--LNKGRP ,Link Group ID ,Char ,"Identifier used to link related records across domains. This will usually be a many-to-one
relationship. For example: Multiple tumor measurements/assessments will contribute to
a single response to therapy determination record."
