...
| Page properties |
|---|
| Title | Psoriasis Area and Severity Index Version Bozek (PASI BOZEK)
|
|---|
| CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
|---|
| QRS Short Name | |
|---|
| QRS Permission Status | Public Domain
|
|---|
| Team | Psoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
|---|
| Supplement Version | 1.0
|
|---|
| Status | DRAFT |
|---|
| Date | 2022-06-2830
|
|---|
| 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 Bozek reference as the standard for responses.
|
|---|
|
Revision History
| Date | Version |
|---|
| 2022-06-2830 | 1.0 Draft |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
...