Variable Name,Variable Label,Type,Description
STUDYID,Study Identifier,Char,Unique identifier for a study.
DOMAIN,Domain Abbreviation,Char,2-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 Table 4.1.3.1, Pool Definition Dataset and Section 6, Applying Model Fundamentals to Associated Persons)."
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.
NHOID,Non-Host Organism Identifier,Char,"Sponsor-defined identifier for a non-host organism. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by the lab. Example: ""A/California/7/2009 (H1N1)""."
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 Information (Section 3.3)."
--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."
