"Variable
Name ",Variable Label ,Type ,Description
STUDYID ,Study Identifier ,Char ,Study Identifier of the domain 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 ,"Name of the identifying variable in the general-observation-class dataset
that identifies the related record(s). Examples include --SEQ and --
GRPID."
IDVARVAL ,Identifying Variable Value ,Char ,"Value of identifying variable described in IDVAR. If --SEQ is the
variable being used to describe this record, then the value of --SEQ
would be entered here."
RELTYPE ,Relationship Type ,Char ,"Identifies the hierarchical level of the records in the relationship. Values
should be either ONE or MANY. However, values are only necessary
when identifying a relationship between datasets."
RELID ,Relationship Identifier ,Char ,"Unique value within USUBJID that identifies the relationship. All
records for the same USUBJID that have the same RELID are
considered “related/associated.” RELID can be any value the sponsor
chooses, and is only meaningful within the RELREC dataset to identify
the related/associated Domain records."
