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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
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
<DECAT codelist>
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).
DESTDAT DESTDTC
_________________
Record where the device incident occurred.What was the setting where the device event occurred?
DESETTNG NSDE.DESETTNG
<SETTING codelist>
Specify the other setting where the incident occurred, if applicable.
DESTNGOT NSDE.DESTNGOT
_________________
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
_________________
OrderTAUG ReferenceCDASHIG VariableQuestion TextPromptData TypeCRF Completion InstructionsSDTMIG TargetSDTM Variable MappingControlled Terminology Codelist NameCRF Implementation NotesPermissible ValuesPre-populated ValueQuery DisplayList StyleHidden
1TAUG-T1D-P&DSPDEVIDWhat device experienced the event?Device Experienced EventtextIndicate 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
2TAUG-T1D-P&DDESPIDWhat is the device event identifier?Device Event Identifiertext
DESPID

Sequential number usually populated by the system for use in associated the event with other CRFs, e.g,. AE
Sponsor-defined

Y
5TAUG-T1D-P&DDECATWhat type of device event was experienced?Type of Device EventtextIndicate 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 capturedDevice operational issue; User error; Inadequate labeling; Other

radio
6TAUG-T1D-P&DDETERM

Describe the device event.

Device EventtextRecord a description of the device event that occurred.DETERM







7TAUG-T1D-P&DDESTDATWhat was the start date when the event first occurred or was identified?Start DatetextRecord 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.




8TAUG-T1D-P&DDESETTNGWhat was the setting where the device event occurred?Event SettingtextRecord where the device incident occurred.NSDE.DESETTNG
(SETTING)
Home; Hospital; Outpatient Clinical; Other

radio
9TAUG-T1D-P&DDESTNGOT

If Other, what was the setting where the device event occurred?

Other Event SettingtextSpecify the other setting where the incident occurred, if applicable.NSDE.DESTNGOT







10TAUG-T1D-P&DDEPATTHow frequently did the event occur?Event FrequencytextRecord how often the incident occurred.DEPATT

Controlled Terminology list (FREQ) can be usedSingle Event; Intermittent; Continuous

radio
11TAUG-T1D-P&DDEACNDEVWhat action was taken with or to study device?Action Taken With DevicetextRecord 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
12TAUG-T1D-P&DDEAENO(n)What was the identifier for the primary adverse event(s) associated with or related to this device event?Related Adverse Event IDtextRecord the ID of the primary AE associated with the device event, if any.N/AASSOCIATE 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

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DI01-ABC1DEVTYPEDevice TypeMouthpiece 
2TOB07DI01-ABC2MANUFManufacturerReliable Devices
3TOB07DI01-ABC3MODELModel Number

 700XYZ

5TOB07DI02-ABC1DEVTYPEDevice TypeCartridge
6TOB07DI02-ABC2MANUFManufacturer ManF A Device
7TOB07DI02-ABC3MODELModel Number 900 Tob

Dataset Debug Messages

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Dataset Wrapper Debug Message

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