| Xformpusher |
|---|
| 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 | TULOC | What was the anatomical region shown by the imaging procedure? | Anatomical Part or Region Shown by the Image |
| TULOC |
|
| This is the general anatomical part or region made available for assessment by the imaging procedure. |
| LOWER LIMB REGION |
|
| Y |
| | 3 | 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 |
|
Location Identification3Result| Was there a lesion present based on the assessment of the image? | Presence of Lesion |
| TUORRES |
| (Y/N |
|
/A | Identified | Y | 4TURESLOC
location of
the lesion based on the assessment of the 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. |
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. |
| Examination for Abnormality |
|
| Y |
| | 6 | text | TUORRES | What was the type of lesion observed based on the assessment of the image? | Lesion Type | Record the type of lesion observed, e.g. aneurysm, calcified annulus, valvular stenosis, etc. | TUORRES when TUTEST = ABNEXAM |
|
|
|
|
| Prompt |
|
|
| | 7 | text | TURESLOC | What was the
location of
the lesion based on the assessment of the image? | Result Anatomical Location | If this location is a graft (or transplant), enter the name of the native tissue, organ or blood vessel on which the graft is built (or in which the transplant is implanted). | TURESLOC when TUTEST = ABNEXAM |
| (LOC) |
|
|
|
|
|
|
| | 8 | text | TURLGFFL | Indicate whether the located lesion is in a graft or transplant. | Graft Result Location Flag | Check "Yes" for this question if the lesion is located in a graft (or transplant) tissue, organ or blood vessel. | NSTU.TURLGFFL |
|
|
| Yes |
|
| checkbox
|
|
| | 9 | text | TURESLAT | If applicable, indicate the laterality of the location of the lesion. | Result Location Laterality |
| TURESLAT when TUTEST = ABNEXAM |
| (LAT) |
|
|
|
|
|
|
| | 10 | text | TURESLDL | If applicable, provide more detail of the location of the lesion. | Result Location directionality |
| TURESLDL when TUTEST = ABNEXAM |
| N/A |
|
|
|
|
|
|
| | 11 | text | TULNKID | What was the
Lesion ID? | Lesion ID | Sponsor-specified | TULNKID, TRLNKID, RSLNKID |
| N/A | This variable is used to provide a unique code for each identified lesion in order to link records across related domains (TU, TR, RS). |
|
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 | N/A