"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 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 ,"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 ,"RELID value should be unique within the ID variable (e.g., USUBJID, APID,
POOLID, SPDEVID) that is the subject of the relationship. All records with this ID
variable 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."
