...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 13-14: | Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX". | | Rows 15-16: | Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX". | | Rows 17-32: | Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was collected, the date is included in QSDTC for when the visit was planned | Row 33: | The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF. | |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 | STUDYX | QS | 2324-P0001 | 1 | MTWSR101 | MTWSR1-Angry, Irritable, Frustrated | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24H | | 2 | STUDYX | QS | 2324-P0001 | 2 | MTWSR102 | MTWSR1-Anxious, Nervous | MTWS-R | Moderate | 3 | 3 |
|
| Y | 1 | 2023-08-13 | -P24H | | 3 | STUDYX | QS | 2324-P0001 | 3 | MTWSR103 | MTWSR1-Depressed Mood, Sad | MTWS-R | Mild | 2 | 2 |
|
| Y | 1 | 2023-08-13 | -P24H | | 4 | STUDYX | QS | 2324-P0001 | 4 | MTWSR104 | MTWSR1-Difficulty Concentrating | MTWS-R | Mild | 2 | 2 |
|
| Y | 1 | 2023-08-13 | -P24H | | 5 | STUDYX | QS | 2324-P0001 | 5 | MTWSR105 | MTWSR1-Inc Appetite, Hungry, Weight Gain | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24H | | 6 | STUDYX | QS | 2324-P0001 | 6 | MTWSR106 | MTWSR1-Sleep Problems/Awakening at Night | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24H | | 7 | STUDYX | QS | 2324-P0001 | 7 | MTWSR107 | MTWSR1-Restless | MTWS-R | Moderate | 3 | 3 |
|
| Y | 1 | 2023-08-13 | -P24H | | 8 | STUDYX | QS | 2324-P0001 | 8 | MTWSR108 | MTWSR1-Impatient | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24H | | 9 | STUDYX | QS | 2324-P0001 | 9 | MTWSR109 | MTWSR1-Craving to Smoke | MTWS-R | Severe | 4 | 4 |
|
| Y | 1 | 2023-08-13 | -P24H | | 10 | STUDYX | QS | 2324-P0001 | 10 | MTWSR110 | MTWSR1-Constipation | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24H | | 11 | STUDYX | QS | 2324-P0001 | 11 | MTWSR111 | MTWSR1-Dizziness | MTWS-R | None | 0 | 0 |
|
| Y | 1 | 2023-08-13 | -P24H | | 12 | STUDYX | QS | 2324-P0001 | 12 | MTWSR112 | MTWSR1-Coughing | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24H | | 13 | STUDYX | QS | 2324-P0001 | 13 | MTWSR113 | MTWSR1-Dreaming or Nightmares | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24H | | 14 | STUDYX | QS | 2324-P0001 | 14 | MTWSR114 | MTWSR1-Nausea | MTWS-R | None | 0 | 0 |
|
| Y | 1 | 2023-08-13 | -P24H | | 15 | STUDYX | QS | 2324-P0001 | 15 | MTWSR115 | MTWSR1-Sore Throat | MTWS-R | None | 0 | 0 |
|
| Y | 1 | 2023-08-13 | -P24H | | 16 | STUDYX | QS | 2324-P0001 | 16 | MTWSR116 | MTWSR1-Total Withdrawal Discomfort Score | MTWS-R | 14 | 14 | 14 |
|
| Y | 1 | 2023-08-13 | -P24H | | 17 | STUDYX | QS | 2324-P0001 | 17 | MTWSR101 | MTWSR1-Angry, Irritable, Frustrated | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 18 | STUDYX | QS | 2324-P0001 | 18 | MTWSR102 | MTWSR1-Anxious, Nervous | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 19 | STUDYX | QS | 2324-P0001 | 19 | MTWSR103 | MTWSR1-Depressed Mood, Sad | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 20 | STUDYX | QS | 2324-P0001 | 20 | MTWSR104 | MTWSR1-Difficulty Concentrating | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 21 | STUDYX | QS | 2324-P0001 | 21 | MTWSR105 | MTWSR1-Inc Appetite, Hungry, Weight Gain | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 22 | STUDYX | QS | 2324-P0001 | 22 | MTWSR106 | MTWSR1-Sleep Problems/Awakening at Night | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 23 | STUDYX | QS | 2324-P0001 | 23 | MTWSR107 | MTWSR1-Restless | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 24 | STUDYX | QS | 2324-P0001 | 24 | MTWSR108 | MTWSR1-Impatient | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 25 | STUDYX | QS | 2324-P0001 | 25 | MTWSR109 | MTWSR1-Craving to Smoke | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 26 | STUDYX | QS | 2324-P0001 | 26 | MTWSR110 | MTWSR1-Constipation | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 27 | STUDYX | QS | 2324-P0001 | 27 | MTWSR111 | MTWSR1-Dizziness | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 28 | STUDYX | QS | 2324-P0001 | 28 | MTWSR112 | MTWSR1-Coughing | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 29 | STUDYX | QS | 2324-P0001 | 29 | MTWSR113 | MTWSR1-Dreaming or Nightmares | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 30 | STUDYX | QS | 2324-P0001 | 30 | MTWSR114 | MTWSR1-Nausea | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 31 | STUDYX | QS | 2324-P0001 | 31 | MTWSR115 | MTWSR1-Sore Throat | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H | | 32 | STUDYX | QS | 2324-P0001 | 32 | MTWSR116 | MTWSR1-Total Withdrawal Discomfort Score | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 |
|
|
info| Dataset wrap |
|---|
| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
STUDYX | QS | P0001 | QSSEQ | Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8) | Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT). | Label for QNAM (e.g., Contact Type) | Value of QNAM variable ( e.g., SUBJECT VISIT) | CRF |
The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes): Text that would remain unchanged has been left in black: The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.
|
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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
...