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 |
| (LOC) |
|
|
|
|
|
|
|
3 | text | DEPRESP |
| Prespecified Device Event |
| DEPRESP |
| N/A |
|
| Y | Prompt |
| Y |
|
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. |
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|