| 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? | Image Location |
| TULOC |
|
| This is the general anatomical part or region made available for assessment by the imaging procedure. If this location is not known, leave TULOC blank. |
| CORONARY VESSEL SYSTEM |
|
| 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 column header. |
| Lesion Location Identification |
|
| Y |
|
| 4 | text | TUORRES |
| Result |
| TUORRES |
| N/A |
|
| IDENTIFIED |
|
| Y |
|
| 5 | 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, enter the name of the native tissue, organ or blood vessel. | TURESLOC when TUTEST = Lesion Location Identification |
| (LOC) |
|
|
|
|
|
|
|
| 7 | text | TURESLAT | If applicable, indicate the laterality of the location of the lesion. | Result Location Laterality |
| TURESLAT when TUTEST = Lesion Location Identification |
| (LAT) |
|
|
|
|
|
|
|
| 8 | text | TURESLDL | If applicable, provide more detail of the location of the lesion. | Result Location directionality |
| TURESLDL when TUTEST = Lesion Location Identification |
| N/A |
|
|
|
|
|
|
|
| 9 | 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). |
|
|
|
|
|
|
| 10 | text | RSCAT | Record the clinical classification used for the assessment of Coronary lesion severity. | Coronary Lesion Severity Clinical Classification |
| RSCAT |
|
|
|
| ACC/AHA CLASSIFICATION OF CORONARY LESIONS |
|
| Y |
|
| 11 | text | RSTEST | What was the severity of the coronary lesion? | Coronary Lesion Severity |
| RSTEST when RSTEST = ACCAHA01-ACC/AHA Classification of Coronary Lesions Type |
|
| If the instrument is considered as a clinical classification (i.e. validated, peer-reviewed public domain or copyrighted instrument), use the combined RS/CC domain and follow CC controlled terminology business rules. | Type A; Type B; Type C |
|
| radio
|
|
|
| 12 | text | RSCAT | Record the clinical classification used for the assessment of coronary arterial perfusion. | Coronary Arterial Perfusion Clinical Classification |
| RSCAT |
|
|
|
| TIMIFLOW |
|
| Y |
|
| 13 | text | RSTEST | How severely was perfusion impacted as a result of the coronary lesion? | Coronary Arterial Perfusion Perfusion Grade |
| RSTEST when RSTEST = TIMI01-TIMI Flow Grade |
|
| If the instrument is considered as a clinical classification (i.e. validated, peer-reviewed public domain or copyrighted instrument), use the combined RS/CC domain and follow CC controlled terminology business rules. | Grade I; Grade II; Grade III; Grade IIII |
|
| radio
|
|
|