This is an example of a study were a heated stick and the associate device were used. The sponsor collected device events for the device and the actual heated stick as a single entity.
SPDEVID
Pre-populated
HEATED STICK DEVICE
DESPID
Hidden/pre-populated
Sponsor-defined
Record a description of the device event that occurred.
DETERM
_________________
Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY).
DESTDATDESTDTC
_________________
Record how often the incident occurred.
How frequently did the event occur?
DEPATT
Record what action was taken with the device as a result of the incident.
What action was taken with or to study device?
DEACNDEV
<DEACNDEV codelist>
Record the ID of the primary AE associated with the device event, if any.
DEAENO(n)ASSOCIATE WITH RELATED RECORD VIA RELREC
_________________
Order
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
Query Display
List Style
Hidden
1
SPDEVID
What device experienced the event?
Device Experienced Event
text
Indicate the device that was involved in the incident.
SPDEVID
.
HEATED STICK DEVICE
radio
2
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
6
DETERM
Describe the device event.
Device Event
text
Record a description of the device event that occurred.
DETERM
7
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
10
DEPATT
How frequently did the event occur?
Event Frequency
text
Record how often the incident occurred.
DEPATT
Single Event; Intermittent; Continuous
radio
11
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
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
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
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
Dataset Debug Messages
There are four leading, trailing, or non-breaking spaces in the dataset.
Shows a malfunction of an MRI calibration affecting 1 subject. In this case the individual MRI unit is not under study (e.g., when the MRI is used to obtain study measurements), and the sponsor decided to use the site number in SPDEVID.
Row 2:
Shows a malfunction of the device under study where all subjects for the day were affected. If this single record is sufficient detail for the sponsor’s requirements, then no further records would be added; if there were a need to associate the malfunction with each subject (e.g., it led to several AEs), then a record could be added for each affected subject. USUBJID is null because this device malfunction was not specific to one subject.
Row 3:
Shows a malfunction for a specific device under study and the associated subject.