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The table represents the items from the C-SSRS BASELINE instrument.
Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.
For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:
| Rows 49-60: | Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. |
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When the reason is collected for a not done visit, information or a row description should be added as follows:
| Rows 49-60: | 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 --DTC for when the visit was planned. |
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We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.
The table represents the items from the QRS Short_Name instrument.
Dataset Wrapper Debug Message
Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.
| 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". |
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| 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". |
| 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. |
Unable to render dataset table
The table contains merged cells. Please unmerge them.
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYX | QS | 2324-P0001 | 1 | IDSR101 | IDSR1-Falling Asleep | IDS-SR | I never take longer than 30 minutes to fall asleep | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 2 | STUDYX | QS | 2324-P0001 | 2 | IDSR102 | IDSR1-Sleep During the Night | IDS-SR | I do not wake up at night | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 3 | STUDYX | QS | 2324-P0001 | 3 | IDSR103 | IDSR1-Waking Up Too Early | IDS-SR | Most of the time, I awaken no more than 30 minutes before I need to get up | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 4 | STUDYX | QS | 2324-P0001 | 4 | IDSR104 | IDSR1-Sleeping Too Much | IDS-SR | I sleep no longer than 7-8 hours/night, without napping during the day | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 5 | STUDYX | QS | 2324-P0001 | 5 | IDSR105 | IDSR1-Feeling Sad | IDS-SR | I feel sad less than half the time | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 6 | STUDYX | QS | 2324-P0001 | 6 | IDSR106 | IDSR1- Feeling Irritable | IDS-SR | I feel irritable less than half the time | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 7 | STUDYX | QS | 2324-P0001 | 7 | IDSR107 | IDSR1-Feeling Anxious or Tense | IDS-SR | I feel anxious (tense) less than half the time | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 8 | STUDYX | QS | 2324-P0001 | 8 | IDSR108 | IDSR1-Your Mood to Good/Desired Events | IDS-SR | My mood brightens but I do not feel like my normal self when good events occur | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 9 | STUDYX | QS | 2324-P0001 | 9 | IDSR109 | IDSR1-Mood in Relation to Time of Day | IDS-SR | My mood often relates to the time of day because of environmental events (e.g., being alone, working) | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 10 | STUDYX | QS | 2324-P0001 | 10 | IDSR109A | IDSR1-Mood Worse Morn/Afternoon/Night | IDS-SR | Afternoon | Afternoon | Y | 1 | 2015-05-15 | -P7D | |
| Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.) | ||||||||||||||
| 33 | STUDYX | QS | 2324-P0001 | 33 | IDSR131 | IDSR1-Score | IDS-SR | 18 | 18 | 18 | Y | 1 | 2015-05-15 | |
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.
STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|---|---|---|---|---|---|---|---|
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 |
4 SDTM Mapping Strategy
The SUPPQS dataset shows the items in the QS dataset which have assigned responses due to conditional branching.
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.
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