Device Event Reporting

Illustrates Domains

Illustrates Variables

DESPID
DETERM
DESETTNG
DEPATT
DEACNDEV
DEAENO(n)

Content

This aCRF shows how data could be collected for events occurring with cannulas. Because the sponsor was only interested in the length of the cannulas and not the individual units, the SDTM unique device identifier SPDEVID could be used in data capture and was set to the catalog number of the infusion set. In addition, the data capture-only variable DEAENO was included to capture the ID of the primary adverse event related to the device event, if any. This variable would not be included in a regulatory submission, but could be used to create a link between the device event and the adverse event in SDTM.

Title: Study Device Events

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 <From 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 <From 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 <From 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	_________________

View CRF Metadata

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.