Page History
...
| Page properties | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
...
Revision History
| Date | Version |
|---|---|
| 2021-07-2628 | 1.0 Draft |
© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
...
There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument.The The creation of this instrument was based on based on published articles describing the instrument and input from PASI PASI V2 subject matter experts . Sponsors Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.
The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.
...
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.
...
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.
...
If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:
"All QSTESTCDs"
...
Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.
...
If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:
QSTESTCD = "test code 1" QSTEST = "test name 1"
QSTESTCD = "test code 4" QSTEST = "test name 4"
QSTESTCD = "test code 5" QSTEST = "test name 5"
QSTESTCD = "test code 6" QSTEST = "test name 6"
QSTESTCD = "test code 7" QSTEST = "test name 7"
QSTESTCD = "test code 8" QSTEST = "test name 8"
QSTESTCD = "test code 15" QSTEST = "test name 15"
QSTESTCD = "test code 22" QSTEST = "test name 22"
QSTESTCD = "test code 27" QSTEST = "test name 27"
QSTESTCD = "test code 29" QSTEST = "test name 29"
RSTESTCD = "PASI0201" RSTEST = "PASI02-Head: Erythema/Redness"
RSTESTCD = "PASI0202" RSTEST = "PASI02-Head: Thickness/Induration"
RSTESTCD = "PASI0203" RSTEST = "PASI02-Head: Desquamation/Scaling"
RSTESTCD = "PASI0205" RSTEST = "PASI02-Up Extrem: Erythema/Redness"
RSTESTCD = "PASI0206" RSTEST = "PASI02-Up Extrem: Thickness/Induration"
RSTESTCD = "PASI0207" RSTEST = "PASI02-Up Extrem: Desquamation/Scaling"
RSTESTCD = "PASI0209" RSTEST = "PASI02-Trunk: Erythema/Redness"
RSTESTCD = "PASI0210" RSTEST = "PASI02-Trunk: Thickness/Induration"
RSTESTCD = "PASI0211" RSTEST = "PASI02-Trunk: Desquamation/Scaling"
RSTESTCD = "PASI0213" RSTEST = "PASI02-Low Extrem: Erythema/Redness"
RSTESTCD = "PASI0214" RSTEST = "PASI02-Low Extrem: Thickness/Induration"
RSTESTCD = "PASI0215" RSTEST = "PASI02-Low Extrem: Desquamation/Scaling"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| None | 0 | 0 |
| Slight | 1 | 1 |
| Mild | 2 | 2 |
| Moderate | 3 | 3 |
| Severe | 4 | 4 |
RSTESTCD = "PASI0204" RSTEST = "PASI02-Head: Area Score"
RSTESTCD = "PASI0208" RSTEST = "PASI02-Up Extrem: Area Score"
RSTESTCD = "PASI0212" RSTEST = "PASI02-Trunk: Area Score"
RSTESTCD = "PASI0216" RSTEST = "PASI02-Low Extrem: Area Score"
| RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| No Involvement | 0 | 0 |
| 1% - 9% | 1 | 1 |
| 10% - 29% | 2 | 2 |
| 30% - 49% | 3 | 3 |
| 50% - 69% | 4 | 4 |
| 70% - 89% | 5 | 5 |
| 90% - 100% | 6 | 6 |
...
Omit the QSSTRESN column when it is not applicable to the dataset.
QSTESTCD = "test code" QSTEST = "test name"
...
For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:
QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through
QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"
...
5 Supplemental Qualifier Name Codes
| Info |
|---|
The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black. Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed. Remove Section 5 if it does not apply to the new instrument. |
The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.
...
| Name | suppqs |
|---|
...
End of Document
Overview
Content Tools