Device Events Example 1

Team needs to decide : The level of modelling devices. We can model the single device with no components and collect AE related to the single device ( electronic cigarette ) . or we can model the components of the device ( a mouthpiece or drip tip, a cartridge (tank), a heating element or atomizer, which is sometimes accompanied by a clearomizer, and a battery.))

Device events in tobacco studies may consist of device problems (which may or may not result in adverse events), device-reported warnings or alarms, calibration events, and replacement of parts. This information is represented in the Device Events (DE) and associated domains. In device studies, cases where the device did not perform as expected are typically called "events" or "incidents," rather than "problems" or "malfunctions," because often the true cause of the issue cannot be determined until a cause analysis is performed. This may or may not be a concern for a given trial depending upon whether the device has already been approved by regulators. Typically, post-approval device studies are less concerned about root-issue attribution.

There is more than one approach to identifying devices in studies. The method chosen will depend upon the granularity at which the sponsor needs to track the devices and will affect how the data are modeled. A device can be identified as a single unit (e.g., a syringe), or its components can be separately identified (e.g., barrel, plunger, needle). The level of granularity a sponsor chooses will be influenced by whether the components will be replaced and/or tracked, and how device/adverse event relationships and actions taken will be assessed.

Indicate the device that was involved in the incident.	What device experienced the event? SPDEVID	01-ABC Reliable Devices CGMon 700 02-ABC Reliable Devices CGMon 900
	Device Event Identifier DESPID Hidden/pre-populated	Sponsor-defined
Indicate the investigator's opinion as to what type of device incident was experienced.	What type of device event was experienced? DECAT	Device operational issue User error Inadequate labeling Other <DECAT codelist>
Record a description of the device event that occurred.	Describe the device event. DETERM	_________________
Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY).	What was the start date when the event first occurred or was identified? DESTDAT DESTDTC	_________________
Record where the device incident occurred.	What was the setting where the device event occurred? DESETTNG NSDE.DESETTNG	Home Hospital Outpatient Clinical Other <SETTING codelist>
Specify the other setting where the incident occurred, if applicable.	If Other, what was the setting where the device event occurred? DESTNGOT NSDE.DESTNGOT	_________________
Record how often the incident occurred.	How frequently did the event occur? DEPATT	Single Event Intermittent Continuous
Record what action was taken with the device as a result of the incident.	What action was taken with or to study device? DEACNDEV	No change Device modified/adjusted Device replaced Removed temporarily Removed <DEACNDEV codelist>
Record the ID of the primary AE associated with the device event, if any.	What was the identifier for the primary adverse event(s) associated with or related to this device event? DEAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC	_________________

Order	TAUG Reference	CDASHIG Variable	Question Text	Prompt	Data Type	CRF Completion Instructions	SDTMIG Target	SDTM Variable Mapping	Controlled Terminology Codelist Name	CRF Implementation Notes	Permissible Values	Pre-populated Value	List Style	Hidden
1	TAUG-T1D-P&D	SPDEVID	What device experienced the event?	Device Experienced Event	text	Indicate the device that was involved in the incident.	SPDEVID			In this case, the sponsor is identifying only the type of device, and not each individual unit. The actual SPDEVID (01-ABC or 02-ABC) would be captured in the field, while the text in the permissible values is shown.	01-ABC Reliable Devices CGMon 700;02-ABC Reliable Devices CGMon 900		radio
2	TAUG-T1D-P&D	DESPID	What is the device event identifier?	Device Event Identifier	text		DESPID			Sequential number usually populated by the system for use in associated the event with other CRFs, e.g,. AE		Sponsor-defined		Y
5	TAUG-T1D-P&D	DECAT	What type of device event was experienced?	Type of Device Event	text	Indicate the investigator's opinion as to what type of device incident was experienced.	DECAT		(DECAT)	This is the investigator's evaluation. In pre-market studies this will not be known until a root cause analysis has occurred; for post-market studies the info can be captured	Device operational issue; User error; Inadequate labeling; Other		radio
6	TAUG-T1D-P&D	DETERM	Describe the device event.	Device Event	text	Record a description of the device event that occurred.	DETERM
7	TAUG-T1D-P&D	DESTDAT	What was the start date when the event first occurred or was identified?	Start Date	text	Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY).	DESTDTC			No end date is included as the device may never be repaired, etc.
8	TAUG-T1D-P&D	DESETTNG	What was the setting where the device event occurred?	Event Setting	text	Record where the device incident occurred.	NSDE.DESETTNG		(SETTING)		Home; Hospital; Outpatient Clinical; Other		radio
9	TAUG-T1D-P&D	DESTNGOT	If Other, what was the setting where the device event occurred?	Other Event Setting	text	Specify the other setting where the incident occurred, if applicable.	NSDE.DESTNGOT
10	TAUG-T1D-P&D	DEPATT	How frequently did the event occur?	Event Frequency	text	Record how often the incident occurred.	DEPATT			Controlled Terminology list (FREQ) can be used	Single Event; Intermittent; Continuous		radio
11	TAUG-T1D-P&D	DEACNDEV	What action was taken with or to study device?	Action Taken With Device	text	Record what action was taken with the device as a result of the incident.	DEACNDEV		(DEACNDEV)		No change; Device modified/adjusted; Device replaced; Removed temporarily; Removed		radio
12	TAUG-T1D-P&D	DEAENO(n)	What was the identifier for the primary adverse event(s) associated with or related to this device event?	Related Adverse Event ID	text	Record the ID of the primary AE associated with the device event, if any.	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC		This field is typically used to help create RELREC in SDTM. Multiple fields (DEAENO1, DEAENOn) may be created.

Rows 1-4:

Show the 3 characteristics chosen to create the device identifier SPDEVID for a CGM. The DEVTYPE is required for all devices in DI; the manufacturer, model, together identify the device to the degree of granularity required in the study.

Rows 5-8:

Show the same 3

characteristics used to create a device identifier (SPDEVID) for a second CGM.

di.xpt

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	01-ABC	1	DEVTYPE	Device Type	Mouthpiece
2	TOB07	DI	01-ABC	2	MANUF	Manufacturer	Reliable Devices
3	TOB07	DI	01-ABC	3	MODEL	Model Number	700XYZ
5	TOB07	DI	02-ABC	1	DEVTYPE	Device Type	Cartridge
6	TOB07	DI	02-ABC	2	MANUF	Manufacturer	ManF A Device
7	TOB07	DI	02-ABC	3	MODEL	Model Number	900 Tob

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Device Events Example 1