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| Date | Version | Summary of Changes |
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| 2021-09-22 | 1.3 Draft | - Converted the supplement to the current WIKI QRS supplement template.
- Annotated CRF updated to the MSG V2.0 annotation guidelines, including following updates:
a. Change of QSEVLINT to QSEVINTX for the Evaluation Interval Text of "Since Last VisitLIFETIME" b. Added annotations for QSSTRESC/QSSTRESN wherever applicable - Added the first assumption to include details on every item of the instrument.
- The QSEVAL and QSEVALID assumption and variables were removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values.
- Added assumptions 4, 5 and 6 for conditional branching. The example was updated to include records for these items.
- Added QSLOBXFL variable to the example to represent a baseline response for visit 1
- Added example to represent skipped visit (visitnum = 2)
- Added QSDRVFL variable to the example to represent items not done due to conditional branching.
- Section 4 (SDTM mapping strategy): Added an additional column in the table for QSTESTCD = "CSS0222BCSS0122B" QSTEST = "CSS02-Most Lethal Attempt Damage" to indicate CRF Text over 200 characters
- Added example for SUPPQS dataset
- Added section 5 Supplemental Qualifier Name Codes.
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| 2014-09-03 | 1.2 | |
| 2013-02-06 | 1.1 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised: - QSSCAT added to be compatible with all CSSR-S questionnaires
- QSTPT replaced with QNAM=EVLINTTX to be compatible with all CSSR-S questionnaires using evaluation intervals
- Corrected "Dose not apply", associated with the Most Severe Ideation, Reasons on page 9 to "Does not apply".
- Added QS terminology reference
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| 2012-08-07 | 1.0 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Released |
| 2012-03-03 | 0.1 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Draft |
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The table represents the items from the C-SSRS BASELINE instrument.
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instrument
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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:
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When the reason is collected for a not done visit, information or a row description should be added as follows:
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| Dataset wrap |
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| Rowcaps |
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| 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". | | 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 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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| 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.) |
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| | 33 | STUDYX | QS | 2324-P0001 | 33 | IDSR131 | IDSR1-Score | IDS-SR | 18 | 18 | 18 | Y | 1 | 2015-05-15 |
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