| 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 when TUTEST = Lesion Location Identification |
| (LOC) |
|
|
|
|
|
|
|
| 5 | text | TURESLAT | If applicable, what
was the laterality
of the anatomical
location? | Result Location Laterality |
| TURESLAT when TUTEST = Lesion Location Identification |
| (LAT) |
|
|
|
|
|
|
|
| 6 | text | TURESLDL | If applicable, provide further details of the the anatomical
location. | Result Location directionality |
| TURESLDL when TUTEST = Lesion Location Identification |
| N/A |
|
|
|
|
|
|
|
| 7 | 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). |
|
|
|
|
|
|