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The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

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1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the PASI EMA in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the PASI EMA:

(European Medical Agency Committee for Medicinal Products for Human Use (CHMP). Guideline on Clinical Investigation of Medicinal Products Indicated for the Treatment of Psoriasis. Published November 18, 2004. [Accessed June 15, 2022]. Available at: https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-indicated-treatment-psoriasis.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the PASI V2:

Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65–ii68.

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the PASI V2 are EMA are listed below.

The PASI V2EMA is a tool used to assess the severity of psoriasis. However, there is no standard set of responses for the PASI that is used throughout the industry. This supplement uses the EMA guidelines for Psoriasis as the standard for responses. The PASI V2 EMA divides the body into 4 sections (i.e.,  headhead, trunk, upper extremities, lower extremities) and assesses symptom severity and the percentage of each area affected by psoriasis. The symptoms are rated on a 5-point scale and the area is rated on a 76-point scale. Subscores for each section of the body and a total score are also captured.

1. The scale points for the symptoms include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "NoneNo symptoms"). For the PASI V2EMA, RSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.

   1. CDISC created a CRF based on the Feldman article EMA guidelines using the symptom terms "erythema/redness", "thickness/induration", and "desquamation/scaling". Per subject-matter expert recommendations, desquamation was included with scaling even though desquamation is not referenced in the Feldman article.
      
2. The scale points for the area include a numeric rating (01-6) and a definition of what is represented by the rating (e.g., 0 1 = "0 (clear)<10%"). For the area, RSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
   

3. The PASI V2 instrument EMA instrument includes subscores and a total score that are considered as captured data on the CRF and are not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the Feldman EMA reference.

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

   2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

4. Records are created in rs.xpt for every item on the instrument: 

   1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE".  If the reason is known, that reason is represented in RSREASND (e.g., RSREASND = "REFUSED"). If the reason is unknown, RSSTAT = "NOT DONE" and RSREASND is missing.

5. Terminology

   1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the PASI

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EMA RS Domain Model

The PASI V2 EMA example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the PASI V2 instrument. The  The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented in RSORRES. This result is then represented as a standard numeric score in RSSTRESN and as a standard character representation in RSSTRESC.

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The table represents the items from the PASI V2 instrumentEMA instrument.

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