VariableName	VariableLabel	Type	Role	Note	Core
STUDYID	Study Identifier	Char	Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	Identifier	Two-character abbreviation for the domain.	Req
USUBJID	Unique Subject Identifier	Char	Identifier	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.	Req
DVSEQ	Sequence Number	Num	Identifier	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req
DVREFID	Reference ID	Char	Identifier	Internal or external identifier.	Perm
DVSPID	Sponsor-Defined Identifier	Char	Identifier	Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on a CRF page.	Perm
DVTERM	Protocol Deviation Term	Char	Topic	Verbatim name of the protocol deviation criterion. Example: IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED. The DVTERM values will map to the controlled terminology in DVDECOD, such as TREATMENT DEVIATION.	Req
DVDECOD	Protocol Deviation Coded Term	Char	Synonym Qualifier	Controlled terminology for the name of the protocol deviation. Examples: SUBJECT NOT WITHDRAWN AS PER PROTOCOL, SELECTION CRITERIA NOT MET, EXCLUDED CONCOMITANT MEDICATION, TREATMENT DEVIATION.	Perm
DVCAT	Category for Protocol Deviation	Char	Grouping Qualifier	Category of the protocol deviation criterion.	Perm
DVSCAT	Subcategory for Protocol Deviation	Char	Grouping Qualifier	A further categorization of the protocol deviation.	Perm
EPOCH	Epoch	Char	Timing	Epoch associated with the start date/time of the deviation. Examples: TREATMENT PHASE, SCREENING, and FOLLOW-UP.	Perm
DVSTDTC	Start Date/Time of Deviation	Char	Timing	Start date/time of deviation represented in ISO 8601 character format.	Perm
DVENDTC	End Date/Time of Deviation	Char	Timing	End date/time of deviation represented in ISO 8601 character format.	Perm