SDTM EM specification

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 device that do not involve subjects, and may even be before the device was in contact with a subject. Should be used when the malfunction is associated with a subject's use or possession of the device.

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 records.

Sponsor-defined reference number.

Perhaps defined in the sponsor's operational database. Note that it does not have to be numeric.

Verbatim name of the observed event.

Examples: "Battery malfunction", "Overheating".

The modified text for EMTERM.

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

Dictionary-derived form of the event described in EMTERM.

Dictionary-derived text description of EMTERM or EMMODIFY. The name and version of the dictionary used to map terms must be provided to reviewers.

Used to define a categorization level for events.

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

Used to define a further category level for events.

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

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

When information about specific events is solicited, 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 EMSTAT was "NOT DONE".

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

EMACNDEV

Describes action taken with respect to the device.

Action Taken may include device replacement, battery replacement, etc.

EMPATT

A characterization of the temporal pattern of occurrences of the 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 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 device event.

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

End date/time of the device event.

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

Study day of Device Event observation, measured as integer days.

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

Study day of start of Device Event, measured as integer days.

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

Study day of end of Device Event, measured as integer days.

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