Record a description of the "other" device event that occurred.
DETERM
_________________
Record the date that the device event first occurred or was noted using the format dd-MON-yyyy
DESTDATDESTDTC
_________________
Record what action was taken with the device as a result of the device event.
What action was taken with respect to the acupuncture needle?
DEACNDEV
<DEACNDEV codelist>
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Order
Type
CDASHIG Variable
Question Text
Prompt
CRF Completion Instructions
SDTMIG Target
SDTMIG Variable Mapping
Controlled Terminology Codelist Name
Implementation Notes
Permissible Values
Pre-populated Value
Query Display
List Style
Hidden
1
text
TUDAT
Collection Date
Collection Date
TUDTC
N/A
Prompt
2
text
TUTEST
What was the lesion identification test name?
Lesion Identification Test Name
Record the name of the TU test, if not printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.
TUTEST
(TUTEST)
Required to identify to which test the result relates. It is recommended that test names be preprinted on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Test can be included as the column header.
Lesion Location Identification
Y
3
text
TURESLOC
What was the location of Lesion based on the assessment of image?
Result Anatomical Location
TURESLOC
(LOC)
4
text
DEOCCUR
Device Event Occurrence
DEOCCUR
N/A
When information about specific events is solicited, DEOCCUR is used to indicate whether or not (Y/N) a particular pre-specified event occurred.
Y
Prompt
Y
4
text
DETERM
If "Other" is selected, please specify the other device event for the needle.
Other Device Event
Record a description of the "other" device event that occurred.
DETERM
N/A
5
text
DESTDAT
What was the start date when the device event first occurred or was identified?
Device Event Start Date
Record the date that the device event first occurred or was noted using the format dd-MON-yyyy
DESTDTC
N/A
No end date is included as the device may never be repaired, etc.
6
text
DEACNDEV
What action was taken with respect to the acupuncture needle?
Action Taken With Device as Result of Device Event
Record what action was taken with the device as a result of the device event.
DEACNDEV
(DEACNDEV)
None; Removal; Other
radio
7
text
DEACNDEV
If "Other" is selected from above, what is the other action taken with, or to acupuncture needle?
Other Action Taken With Device as Result of Device Event
Record the "other" action taken with the device as a result of the incident.