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| Rows 131-1416: | 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. | | Show the symptom and area responses for the baseline visit. | | Rows 17-29: | Show the subscores and total scores for the baseline visit. | | Rows 30-59: | Show that the subject did not participate in the PASI V2 at their second visit. |
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSSTAT | RSREASND | RSLOBXFL | VISITNUM | RSDTCRSEVLINT |
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| 1 | STUDYX | RS | 2324-P0001 | 1 | PASI0201 | PASI02-Head: Erythema/Redness
| PASI V2 | Slight | 010 | 1 |
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| Y | 1 | 2015-05-15-P7D | | 2 | STUDYX | RS | 2324-P0001 | 2 | PASI0202 | PASI02-Head: Thickness/Induration
| PASI V2 | None | 0 | 0 |
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| Y | 1 | 2015-05-15-P7D | | 3 | STUDYX | RS | 2324-P0001 | 3 | PASI0203 | PASI02-Head: Desquamation/Scaling
| PASI V2 | None | 0 | 0 |
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| Y | 1 | 2015-05-15-P7D | | 4 | STUDYX | RS | 2324-P0001 | 4 | PASI0204 | PASI02-Head: Area Score
| PASI V2 | 0 | 1% - 9% | 1 | 10 |
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| Y | 1 | 2015-05-15-P7D | | 5 | STUDYX | RS | 2324-P0001 | 5 | PASI0205 | PASI02-Up Extrem: Erythema/Redness
| PASI V2 | Mild | 211 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 6 | STUDYX | RS | 2324-P0001 | 6 | PASI0206 | PASI02-Up Extrem: Thickness/Induration
| PASI V2 | Slight | 1 | 1 |
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| Y | 1 | 2015-05-15-P7D | | 7 | STUDYX | RS | 2324-P0001 | 7 | PASI0207 | PASI02-Up Extrem: Desquamation/Scaling
| PASI V2 | Mild | 121 | 2 |
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| Y | 1 | 2015-05-15-P7D | | 8 | STUDYX | RS | 2324-P0001 | 8 | PASI0208 | PASI02-Up Extrem: Area Score
| PASI V2 | 1 | 30% - 49% | 3 | 31 |
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| Y | 1 | 2015-05-15-P7D | | 9 | STUDYX | RS | 2324-P0001 | 9 | PASI0209 | PASI02-Trunk: Erythema/Redness
| PASI V2 | None | 101 | 0 |
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| Y | 1 | 2015-05-15-P7D | | 10 | STUDYX | RS | 2324-P0001 | 10 | PASI0210 | PASI02-Trunk: Thickness/Induration
| PASI V2 | None | Afternoon0Afternoon | 0 |
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| Y | 1 | 2015-05-15-P7D | | 11 | STUDYX | RS | 2324-P0001 | 11 | PASI0211 | PASI02-Trunk: Desquamation/Scaling
| PASI V2 | AfternoonNoneAfternoon | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 12 | STUDYX | RS | 2324-P0001 | 12 | PASI0212 | PASI02-Trunk: Area Score
| PASI V2 | Afternoon | No Involvment | 0 | 0Afternoon |
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| Y | 1 | 2015-05-15-P7D | | 13 | STUDYX | RS | 2324-P0001 | 13 | PASI0213 | PASI02-Low Extrem: Erythema/Redness
| PASI V2 | Slight | Afternoon1Afternoon | 1 |
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| Y | 1 | 2015-05-15-P7D | | 14 | STUDYX | RS | 2324-P0001 | 14 | PASI0214 | PASI02-Low Extrem: Thickness/Induration
| PASI V2 | Slight | Afternoon1Afternoon | 1 |
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| Y | 1 | 2015-05-15-P7D | | 15 | STUDYX | RS | 2324-P0001 | 15 | PASI0215 | PASI02-Low Extrem: Desquamation/Scaling
| PASI V2 | Slight | 1AfternoonAfternoon | 1 |
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| Y | 1 | 2015-05-15-P7D | | 16 | STUDYX | RS | 2324-P0001 | 16 | PASI0216 | PASI02-Low Extrem: Area Score
| PASI V2 | 10% - 29% | Afternoon1Afternoon | 1 |
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| Y | 1 | 2015-05-15-P7D | | 17 | STUDYX | RS | 2324-P0001 | 17 | PASI0217 | PASI02-Head: Sum of Symptom Scores
| PASI V2 | 1 | Afternoon1Afternoon | 1 |
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| Y | 1 | 2015-05-15-P7D | | 18 | STUDYX | RS | 2324-P0001 | 18 | PASI0218 | PASI02-Head: Sum X Area
| PASI V2 | Afternoon1Afternoon | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 19 | STUDYX | RS | 2324-P0001 | 19 | PASI0219 | PASI02-Head: Sum X Area X 0.1
| PASI V2 | Afternoon | 0.1 | 0.1 | 0.1Afternoon |
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| Y | 1 | 2015-05-15-P7D | | 20 | STUDYX | RS | 2324-P0001 | 20 | PASI0220 | PASI02-Up Extrem: Sum of Symptom Scores
| PASI V2 | 5 | Afternoon5Afternoon | 5 |
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| Y | 1 | 2015-05-15-P7D | | 21 | STUDYX | RS | 2324-P0001 | 21 | PASI0221 | PASI02-Up Extrem: Sum X Area
| PASI V2 | 15 | Afternoon15Afternoon | 15 |
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| Y | 1 | 2015-05-15-P7D | | 22 | STUDYX | RS | 2324-P0001 | 22 | PASI0222 | PASI02-Up Extrem: Sum X Area X 0.2
| PASI V2 | 3 | Afternoon3Afternoon | 3 |
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| Y | 1 | 2015-05-15-P7D | | 23 | STUDYX | RS | 2324-P0001 | 23 | PASI0223 | PASI02-Trunk: Sum of Symptom Scores
| PASI V2 | 0 | Afternoon0Afternoon | 0 |
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| Y | 1 | 2015-05-15-P7D | | 24 | STUDYX | RS | 2324-P0001 | 24 | PASI0224 | PASI02-Trunk: Sum X Area
| PASI V2 | 0 | Afternoon0Afternoon | 0 |
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| Y | 1 | 2015-05-15-P7D | | 25 | 25 | STUDYX | RS | 2324-P0001 | 25 | PASI0225 | PASI02-Trunk: Sum X Area X 0.3
| PASI V2 | 0 | 0AfternoonAfternoon | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 26 | STUDYX | RS | 2324-P0001 | 26 | PASI0226 | PASI02-Low Extrem: Sum of Symptom Scores
| PASI V2 | 3 | Afternoon3Afternoon | 3 |
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| Y | 1 | 2015-05-15-P7D | | 27 | STUDYX | RS | 2324-P0001 | 27 | PASI0227 | PASI02-Low Extrem: Sum X Area
| PASI V2 | 3 | Afternoon3Afternoon | 3 |
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| Y | 1 | 2015-05-15-P7D | | 28 | STUDYX | RS | 2324-P0001 | 28 | PASI0228 | PASI02-Low Extrem: Sum X Area X 0.4
| PASI V2 | Afternoon | 1.2 | 1.2 | 1.2Afternoon |
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| Y | 1 | 2015-05-15-P7D | | 29 | STUDYX | RS | 2324-P0001 | 29 | PASI0229 | PASI02-Total Sum
| PASI V2 | Afternoon | | 4.3 | 4.3 | 4.3Afternoon |
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| Y | 1 | 2015-05-15 | | 30 | -P7DSTUDYX |
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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 | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 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 |
| RS | 2324-P0001 | 30 | PASI0201 | PASI02-Head: Erythema/Redness
| PASI V2 |
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| NOT DONE | REFUSED |
| 2 | 2015-06-14 | | 31 | STUDYX | RS | 2324-P0001 | 31 | PASI0202 | PASI02-Head: Thickness/Induration
| PASI V2 |
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| NOT DONE | REFUSED |
| 2 | 2015-06-14 | | 32 | STUDYX | RS | 2324-P0001 | 32 | PASI0203 | PASI02-Head: Desquamation/Scaling
| PASI V2 |
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| NOT DONE | REFUSED |
| 2 | 2015-06-14 | | ... |
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| | 59 | STUDYX | RS | 2324-P0001 | 59 | PASI0229 | PASI02-Total Sum
| PASI V2 |
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| NOT DONE | REFUSED |
| 2 | 2015-06-14 |
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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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Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.
If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.
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the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.
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For QRS instruments with subcategories: When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results. QSSCAT alignment with QSTESTCD As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF. | QSSCAT | QSTESTCD |
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| EMOTIONAL/INFORMATIONAL SUPPORT | QSSS0101 - QSSS0108 | | TANGIBLE SUPPORT | QSSS0109 - QSSS0112 | | AFFECTIONATE SUPPORT | QSSS0113 - QSSS0115 | | POSITIVE SOCIAL INTERACTION | QSSS0116 - QSSS0118 | | ADDITIONAL ITEM | QSSS0119 |
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