...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-4: | Show a subject who refused to do the test. All 4 questions were marked as not done with the reason written at the top of the CRF. | | Rows 5-8: | Show a subject who was not able to do the test due to disease progression. Rows 6 and 7 are logically skipped items because the subject was not able to do the 4-stair descend. The test grade is shown on row 8. | | Rows 9-12: | Show a subject who was able to complete the test. | |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | FTSEQ | FTTESTCD | FTTEST | FTCAT | FTORRES | FTSTRESC | FTSTRESN | FTSTAT | FTREASND | FTLOBXFL | VISITNUM | FTDTC |
|---|
| 1 | STUDYX | FT | 1001-001 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4-STAIR DESCEND |
|
|
| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 2 | STUDYX | FT | 1001-001 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4-STAIR DESCEND |
|
|
| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 3 | STUDYX | FT | 1001-001 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4-STAIR DESCEND |
|
|
| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 4 | STUDYX | FT | 1001-001 | 4 | D4STR104 | D4STR1-Test Grade | 4-STAIR DESCEND |
|
|
| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 5 | STUDYX | FT | 1001-002 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4-STAIR DESCEND | No, Due to disease under study | No, Due to disease under study |
|
|
| Y | 1 | 2015-05-15 | | 6 | STUDYX | FT | 1001-002 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4-STAIR DESCEND |
|
|
| NOT DONE | LOGICALLY SKIPPED ITEM |
| Y | 1 | 2015-05-15 | | 7 | STUDYX | FT | 1001-002 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4-STAIR DESCEND |
|
|
| NOT DONELOGICALLY SKIPPED ITEM |
| Y | 1 | 2015-05-15 | | 8 | STUDYX | FT | 1001-002 | 4 | D4STR104 | D4STR1-Test Grade | 4-STAIR DESCEND | Unable to descend 4 standard stairs. | 1 | 1 |
|
| Y | 1 | 2015-05-15 | | 9 | STUDYX | FT | 1001-003 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4-STAIR DESCEND | Yes | Y |
|
|
| Y | 1 | 2015-05-15 | | 10 | STUDYX | FT | 1001-003 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4-STAIR DESCEND | PT1M32S | PT1M32S |
|
|
| Y | 1 | 2015-05-15 | | 11 | STUDYX | FT | 1001-003 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4-STAIR DESCEND | No | N |
|
|
| Y | 1 | 2015-05-15 | | 12 | STUDYX | FT | 1001-003 | 4 | D4STR104 | D4STR1-Test Grade | 4-STAIR DESCEND | Descends 4 standard stairs alternating feet, needs handrail for support. | 5 | 5 |
|
| Y | 1 | 2015-05-15 | |
The conditionally branched item flag text value for data collection needs to be populated in SUPPFT as follows. The standard terminology for QNAM and QLABEL are listed below. | Dataset wrap |
|---|
| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| STUDYX | FT | 1001-002 | QSSEQ | 2 | FTCBRFL | Conditionally Branched Item Flag | Y | CRF | | STUDYX | FT | 1001-002 | QSSEQ | 3 | FTCBRFL | Conditionally Branched Item Flag | Y | CRF |
|
|
4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM FT domain. It also provides guidance on how the result and unit variables (FTORRES, FTSTRESC, FTSTRESN, FTORRESU, and FTSTRESU)| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | QRSSUPP-620 |
|---|
|
should be populated.
...