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Title

Psoriasis Area and Severity Index Version EMA (PASI EMA)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

PASI EMA

QRS Permission StatusPublic Domain
TeamPsoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2022-0607-2924
Notes
  • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
Known Issue(s)
  • Version 1 of the Psoriasis Area and Severity Index CDISC Controlled Terminology (RSCAT=PASI with synonym=PASI01) is scheduled for deprecation and an associated QRS supplement will not be released.
  • There is not general agreement between industry, regulators, and academia on a standard set of responses for the PASI. Therefore, CDISC has created separate terminology and supplements for multiple references with different sets of responses for the PASI. This supplement uses the EMA guidelines for Psoriasis as the standard for responses.

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Revision History

DateVersion
2022-0607-29241.0 Draft

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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  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 = "No symptoms"). For the PASI EMA, 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 EMA guidelines using the symptom terms "erythema/redness," , "thickness/induration," , and "desquamation/scaling." . Per subject-matter expert recommendations, these terms were included even though not all of them were referenced in the EMA article.
  2. The scale points for the area include a numeric rating (1-6) and a definition of what is represented by the rating (e.g., 1 = "<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 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 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.

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