Psoriasis Area and Severity Index Version EMA (PASI EMA)
CDISC Reference
Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name
PASI EMA
QRS Permission Status
Public Domain
Team
Psoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version
1.0
Status
DRAFT
Date
2022-06-29
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.