VariableName	VariableLabel	Type	Controlled Terms, Codelist or Format	Role	Definition	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	DX	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
SPDEVID	Sponsor Device Identifier	Char		Identifier	Sponsor-defined identifier for the device.	Req
DXSEQ	Sequence Number	Num		Identifier	Sequence Number given to ensure uniqueness of device records within subject records within a domain.	Req
DXGRPID	Group ID	Char		Identifier	Identifier that ties together a block of related records in a single domain for a subject.	Perm
DXSPID	Sponsor-Defined Identifier	Char		Identifier	Sponsor-defined reference number.	Perm
DXTRT	Name of Device Exposure or Output	Char		Topic	Name of the device or the exposure outputs that are delivered or administered via the device. This should match the definitions as described in the trial summary domain and/or the protocol.	Req
DXCAT	Category for Device Exposure	Char	*	Grouping Qualifier	Used to define a category of device exposures	Perm
DXSCAT	Subcategory for Device Exposure	Char	*	Grouping Qualifier	A further categorization of device exposures	Perm
DXDOSE	Exposure per Administration	Num		Record Qualifier	Amount of DXTRT administered/delivered per administration.	Perm
DXDOSTXT	Device Exposure Description	Char		Record Qualifier	Exposure amounts or a range of exposure information collected in text form.	Perm
DXDOSU	Device Exposure Units	Char	( UNIT )	Variable Qualifier	Units for DXDOSE, DXDOSTXT, and DXDOSTOT.	Perm
DXDOSFRQ	Device Exposure Frequency per Interval	Char	( FREQ )	Variable Qualifier	Exposure frequency per interval.	Perm
DXDOSTOT	Total Daily Device Exposure	Num		Record Qualifier	Total daily exposure of DXTRT using the units in DXDOSU	Perm
DXDOSRGM	Intended Device Exposure Regimen	Char		Variable Qualifier	Text description of the (intended) schedule or regimen for the Intervention.	Perm
DXROUTE	Route of Administration	Char	( ROUTE )	Variable Qualifier	Route of administration for DXTRT.	Perm
DXLOC	Location of Device Exposure	Char		Record Qualifier	Anatomic location of exposure	Perm
DXLAT	Laterality of Device Exposure	Char		Variable Qualifier	Qualifier for anatomical location further detailing laterality
DXMETHOD	Method of Device Exposure	Char	*	Record Qualifier	Method of device exposure.	Perm
DXADJ	Reason for Exposure Adjustment	Char		Record Qualifier	Describes reason why the exposure was adjusted from protocol-specified or expected exposure levels.	Perm
DXSTDTC	Start Date/Time of Device Exposure	Char	ISO 8601	Timing	Start date and time of exposure	Exp
DXENDTC	End Date/Time of Device Exposure	Char	ISO 8601	Timing	End date and time of exposure.	Perm
DXSTDY	Study Day of Start of Device Exposure	Num		Timing	Study day of start of exposure.	Perm
DXENDY	Study Day of End of Device Exposure	Num		Timing	Study day of end of exposure	Perm
DXDUR	Duration of Device Exposure	Char	ISO 8601	Timing	Collected duration for a treatment episode.	Perm