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