| 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 | TUORRES |
| Result |
| TUORRES |
| N/A |
|
| Identified |
|
| Y |
| | 4 | text | TURESLOC | What was the
location of
the lesion based on the assessment of the image? | Result Anatomical Location |
| TURESLOC |
| (LOC) | 4DEOCCUR | 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 | | TURESLAT | If applicable, what
was the laterality
of the anatomical
location? | Result Location Laterality |
| TURESLAT |
| (LAT) |
|
|
|
|
|
|
| | 6 | text | TURESLDL | If applicable, provide further details of the location | Result Location directionality |
| TURESLDL |
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. | DEACNDEV
|