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Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

Permissible rather than required because events may happen to or with a tobacco product device that do not involved involve subjects, and may even be before the tobacco product device was in contact with a subject. In these cases there may not be a value for USUBJID.

Should be used when the malfunction is associated with a subject's use or possession of the tobacco product device.

Sponsor-defined identifier for the device.

It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers).

Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product.

Sequence Number given to ensure uniqueness of device records within subject records within a domain.May be any valid number. It should be unique within every subject/device combination. If there is no USUBJID associated with the event, DESEQ should be unique within each SPDEVID.

SponsorApplicant-defined reference number.

Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsorapplicant's operational database. Note that it does not have to be numeric.

Verbatim name of the observed event.

Examples: "Screw BreakageBattery malfunction", "Fissure Formation", "Battery IssueOverheating".

The modified text for DETERMEMTERM.

If DETERM EMTERM is modified, then the modified text is placed here.

Dictionary-derived text description of EMTERM or EMMODIFY. Note: CDISC does not prescribe what standardized or dictionary-derived text should be used.

form of the event described in DETERM.Dictionary-derived text description of DETERM or DEMODIFY. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList elementto reviewers.

Used to define a categorization level for events.

For example, "MALFUNCTION" vs. "CALIBRATION".

Used to define a further category level for events.For example, "EXTERNAL" vs. "INTERNAL".

Used to indicate whether (Y/null) information about a specific event was solicited on the CRF.

For example, DETERM EMTERM could contain a list of malfunctions that are being specifically evaluated. DEPRESP EMPRESP would identify those (Y), whereas any spontaneous events would have DEPREST EMPRESP null.

When information about specific events is solicited, DEOCCUR EMOCCUR is used to indicate whether or not (Y/N) a particular pre-specified event occurred.

Values are null for events not specifically solicited.

The status indicates that the pre-specified question was not answered.

For example, if equipment operation requires checking, such as checking an event log to detect events. Capturing that the checks were not completed may be relevant to interpreting the study data.

Reason DESTAT EMSTAT was "NOT DONE".

This variable should only be used if there are pre-specified events.

EMACNDEV

Describes Action Taken action taken with respect to the tobacco product device.

Action Taken may include removal, calibration, reprogramming, and so on. Action is usually in response to some event, for example, a subject's adverse eventtobacco product device replacement, battery replacement, etc.

EMPATT

A characterization of the temporal pattern of occurrences of the tobacco product device event or malfunction.

Clinical encounter number.

Numeric version of VISIT, used for sorting.

Protocol-defined description of clinical encounter.

May be used in addition to VISITNUM and/or VISITDY.

Planned study day of the visit based upon RFSTDTC in Demographics.

This value is usually derived.

Date the tobacco product device event information was collected.

This may be reported if the event (e.g., malfunction) is discovered on a different date from the event.

Start date/time of the tobacco product device event.

If the event happened at a single point in time, DESTDTC EMSTDTC is used.

End date/time of the tobacco product device event.

If an event lasted over a period of time, DEENDTC EMENDTC can be used to capture the end date/time.

Study day of Device Event tobacco product device event observation, measured as integer days.

Algorithm for calculations must be relative to the sponsorapplicant-defined RFSTDTC variable in Demographics.

Study day of start of Device Eventtobacco product device event, measured as integer days.

Algorithm for calculations must be relative to the sponsorapplicant-defined RFSTDTC variable in Demographics.

Study day of end of Device Eventtobacco product device event, measured as integer days.

Algorithm for calculations must be relative to the sponsorapplicant-defined RFENDTC variable in Demographics.