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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:
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| Rows 7-8: | Represent the conditional branching on data entry where Ideation With Intent, No Plan is "No" and the associated description is missing. | | Rows 9-10: | Represent the conditional branching on data entry where Ideation With Plan/Intent is "No" and the associated description is missing. | | Rows 25-27: | Represent the conditional branching on data entry where Aborted Attempt is "No". The Number of Aborted Attempts and the associated description are missing. | | Rows 40-79: | Show the subject was not evaluated on this instrument at the baseline visit. 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:
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 | STUDYX | QS | 2324-P0001 | 1 | CSS0901 | CSS09-Wish to be Dead | C-SSRS SCREENING | SUICIDAL IDEATION | Yes | Y |
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| Y | 1 | 2013-09-13 | -P1M | | 2 | STUDYX | QS | 2324-P0001 | 2 | CSS0901A | CSS09-Wish to be Dead, Describe | C-SSRS SCREENING | SUICIDAL IDEATION | Wish dead | Wish dead |
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| Y | 1 | 2013-09-13 | -P1M | | 3 | STUDYX | QS | 2324-P0001 | 3 | CSS0902 | CSS09-Non-Spec Suicid Thought | C-SSRS SCREENING | SUICIDAL IDEATION | Yes | Y |
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| Y | 1 | 2013-09-13 | -P1M | | 4 | STUDYX | QS | 2324-P0001 | 4 | CSS0902A | CSS09-Non-Spec Suicid Thought, Describe | C-SSRS SCREENING | SUICIDAL IDEATION | I have thought about killing myself | I have thought about killing myself |
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| Y | 1 | 2013-09-13 | -P1M | | 5 | STUDYX | QS | 2324-P0001 | 5 | CSS0903 | CSS09-Idea, No Intent, No Plan | C-SSRS SCREENING | SUICIDAL IDEATION | Yes | Y |
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| Y | 1 | 2013-09-13 | -P1M | | 6 | STUDYX | QS | 2324-P0001 | 6 | CSS0903A | CSS09-Idea, No Intent, No Plan, Describe | C-SSRS SCREENING | SUICIDAL IDEATION | I thought about taking an overdose but I never made a specific plan | I thought about taking an overdose but I never made a specific plan |
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| Y | Y | 2013-09-13 | -P1M | | 7 | STUDYX | QS | 2324-P0001 | 7 | CSS0904 | CSS09-Idea, Intent, No Plan | C-SSRS SCREENING | SUICIDAL IDEATION | No | N |
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| Y | 1 | 2013-09-13 | -P1M | | 8 | STUDYX | QS | 2324-P0001 | 8 | CSS0904A | CSS09-Idea, Intent, No Plan, Describe | C-SSRS SCREENING | SUICIDAL IDEATION |
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| NOT DONE |
| 1 | 2013-09-13 | -P1M | | 9 | STUDYX | QS | 2324-P0001 | 9 | CSS0905 | CSS09-Idea, Plan, Intent | C-SSRS SCREENING | SUICIDAL IDEATION | No | N |
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| Y | 1 | 2013-09-13 | -P1M | | 10 | STUDYX | QS | 2324-P0001 | 10 | CSS0905A | CSS09-Idea, Plan, Intent, Describe | C-SSRS SCREENING | SUICIDAL IDEATION |
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| NOT DONE |
| 1 | 2013-09-13 | -P1M | | 11 | STUDYX | QS | 2324-P0001 | 11 | CSS0906 | CSS09-Most Severe Idea | C-SSRS SCREENING | INTENSITY OF IDEATION | 2 | 2 | 2 |
| Y | 1 | 2013-09-13 | -P1M | | 12 | STUDYX | QS | 2324-P0001 | 12 | CSS0906A | CSS09-Most Severe Idea, Desc | C-SSRS SCREENING | INTENSITY OF IDEATION | Some intent to act on suicidal thoughts | Some intent to act on suicidal thoughts |
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| Y | 1 | 2013-09-13 | -P1M | | 13 | STUDYX | QS | 2324-P0001 | 13 | CSS0907 | CSS09-Most Severe Idea, Frequency | C-SSRS SCREENING | INTENSITY OF IDEATION | 2-5 times in week | 3 | 3 |
| Y | 1 | 2013-09-13 | -P1M | | 14 | STUDYX | QS | 2324-P0001 | 14 | CSS0908 | CSS09-Most Severe Idea, Duration | C-SSRS SCREENING | INTENSITY OF IDEATION | Less than 1 hour/some of the time | 2 | 2 |
| Y | 1 | 2013-09-13 | -P1M | | 15 | STUDYX | QS | 2324-P0001 | 15 | CSS0909 | CSS09-Most Severe Idea, Controllability | C-SSRS SCREENING | INTENSITY OF IDEATION | Can control thoughts with a lot of difficulty | 4 | 4 |
| Y | 1 | 2013-09-13 | -P1M | | 16 | STUDYX | QS | 2324-P0001 | 16 | CSS0910 | CSS09-Most Severe Idea, Deterrents | C-SSRS SCREENING | INTENSITY OF IDEATION | Deterrents definitely did not stop you | 5 | 5 |
| Y | 1 | 2013-09-13 | -P1M | | 17 | STUDYX | QS | 2324-P0001 | 17 | CSS0911 | CSS09-Most Severe Idea, Reasons | C-SSRS SCREENING | INTENSITY OF IDEATION | Mostly to get attention, revenge or a reaction from others | 2 | 2 |
| Y | 1 | 2013-09-13 | -P1M | | 18 | STUDYX | QS | 2324-P0001 | 18 | CSS0912 | CSS09-Actual Attempt | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2013-09-13 | -P2Y | | 19 | STUDYX | QS | 2324-P0001 | 19 | CSS0913 | CSS09-Number of Actual Attempts | C-SSRS SCREENING | SUICIDAL BEHAVIOR | 2 | 2 | 2 |
| Y | 1 | 2013-09-13 | -P2Y | | 20 | STUDYX | QS | 2324-P0001 | 20 | CSS0913A | CSS09-Actual Attempt, Describe | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Try to get injured to get attention | Try to get injured to get attention |
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| Y | 1 | 2013-09-13 | -P2Y | | 21 | STUDYX | QS | 2324-P0001 | 21 | CSS0914 | CSS09-Non-suicidal Self-injur Behav | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2013-09-13 | -P2Y | | 22 | STUDYX | QS | 2324-P0001 | 22 | CSS0915 | CSS09-Interrupted Attempt | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2013-09-13 | -P2Y | | 23 | STUDYX | QS | 2324-P0001 | 23 | CSS0916 | CSS09-Number of Interrupt Attempts | C-SSRS SCREENING | SUICIDAL BEHAVIOR | 1 | 1 | 1 |
| Y | 1 | 2013-09-13 | -P2Y | | 24 | STUDYX | QS | 2324-P0001 | 24 | CSS0916A | CSS09-Interrupted Attempt, Describe | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Stopped from overdose | Stopped from overdose |
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| Y | 1 | 2013-09-13 | -P2Y | | 25 | STUDYX | QS | 2324-P0001 | 25 | CSS0917 | CSS09-Aborted Attempt | C-SSRS SCREENING | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2013-09-13 | -P2Y | | 26 | STUDYX | QS | 2324-P0001 | 26 | CSS0918 | CSS09-Number of Aborted Attempts | C-SSRS SCREENING | SUICIDAL BEHAVIOR |
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| NOT DONE |
| 1 | 2013-09-13 | -P2Y | | 27 | STUDYX | QS | 2324-P0001 | 27 | CSS0918A | CSS09-Aborted Attempt, Describe | C-SSRS SCREENING | SUICIDAL BEHAVIOR |
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| NOT DONE |
| 1 | 2013-09-13 | -P2Y | | 28 | STUDYX | QS | 2324-P0001 | 28 | CSS0919 | CSS09-Preparatory Acts/Behavior | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2013-09-13 | -P2Y | | 29 | STUDYX | QS | 2324-P0001 | 29 | CSS0919A | CSS09-Preparatory Acts/Behavior, Descr | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Buying pills | Buying pills |
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| Y | 1 | 2013-09-13 | -P2Y | | 30 | STUDYX | QS | 2324-P0001 | 30 | CSS0920 | CSS09-Suicidal Behavior | C-SSRS SCREENING | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2013-09-13 | -P2Y | | 31 | STUDYX | QS | 2324-P0001 | 31 | CSS0921A | CSS09-Most Recent Attempt Date | C-SSRS SCREENING | SUICIDAL BEHAVIOR | 2010-11-09 | 2010-11-09 |
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| Y | 1 | 2013-09-13 | -P2Y | | 32 | STUDYX | QS | 2324-P0001 | 32 | CSS0921B | CSS09-Most Recent Attempt Damage | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Minor physical damage | 1 | 1 |
| Y | 1 | 2013-09-13 | -P2Y | | 33 | STUDYX | QS | 2324-P0001 | 33 | CSS0921C | CSS09-Most Recent Attempt Potential | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Behavior likely to result in injury but not likely to cause death | 1 | 1 |
| Y | 1 | 2013-09-13 | -P2Y | | 34 | STUDYX | QS | 2324-P0001 | 34 | CSS0922A | CSS09-Most Lethal Attempt Date | C-SSRS SCREENING | SUICIDAL BEHAVIOR | 2009-03-27 | 2009-03-27 |
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| Y | 1 | 2013-09-13 | -P2Y | | 35 | STUDYX | QS | 2324-P0001 | 35 | CSS0922B | CSS09-Most Lethal Attempt Damage | C-SSRS SCREENING | SUICIDAL BEHAVIOR | No physical damage or very minor physical damage | 0 | 0 |
| Y | 1 | 2013-09-13 | -P2Y | | 36 | STUDYX | QS | 2324-P0001 | 36 | CSS0922C | CSS09-Most Lethal Attempt Potential | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Behavior not likely to result in injury | 0 | 0 |
| Y | 1 | 2013-09-13 | -P2Y | | 37 | STUDYX | QS | 2324-P0001 | 37 | CSS0923A | CSS09-First Attempt Date | C-SSRS SCREENING | SUICIDAL BEHAVIOR | 2009-02-12 | 2009-02-12 |
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| Y | 1 | 2013-09-13 | -P2Y | | 38 |
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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.
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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". |
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| 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. |
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Unable to render dataset table
The table contains merged cells. Please unmerge them.
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| CSS09-First Attempt Damage | C-SSRS SCREENING | SUICIDAL BEHAVIOR | No physical damage or very minor physical damage | 0 | 0 |
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| CSS09-First Attempt Potential | C-SSRS SCREENING | SUICIDAL BEHAVIOR | Behavior likely to result in injury but not likely to cause death | 1 | 1 |
| Y | 1 | 2013-09-13 | -P2Y | | 40 | STUDYX | QS | 2324-P0002 | 1 | CSS0901 | CSS09-Wish to be Dead | C-SSRS SCREENING | SUICIDAL IDEATION |
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| CSS09-Wish to be Dead, Describe | C-SSRS SCREENING | SUICIDAL IDEATION |
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| NOT DONE |
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| | … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | | 79 | STUDYX | QS | 2324-P0002 | 39 | CSS0923C | CSS09-First Attempt Potential | C-SSRS SCREENING | SUICIDAL BEHAVIOR |
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| NOT DONE |
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The SUPPQS dataset shows the items in the QS dataset which have assigned responses due to conditional branching.
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0001 | QSSEQ | 10 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED |
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| 29 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0001 | QSSEQ | 33 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED |
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| QSSEQ | 36 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 2 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED |
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| P0002 | QSSEQ | 4 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 5 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | … | … | … | … |
| … | … | … | … | | STUDYX | QS | 2324-P0002 | QSSEQ | 17 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED |
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| P0002 | QSSEQ | 19 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 20 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED |
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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.
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STUDYID
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RDOMAIN
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USUBJID
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IDVAR
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IDVARVAL
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QNAM
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QLABEL
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QVAL
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QORIG
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STUDYID
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RDOMAIN
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USUBJID
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IDVAR
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IDVARVAL
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QNAM
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QLABEL
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QVAL
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QORIG
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| P0002 | QSSEQ | 23 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 24 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 26 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 27 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 31 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 32 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 33 | QSCBRFL | Conditional Branching Item Indicator | Y | |
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4 SDTM Mapping Strategy
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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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