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."
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
--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."
--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."
