Clinical Classification (or 'Clinical Classification' or 'Functional Test', as appropriate)Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name
QSU-Brief
QRS Permission Status
Approved(or 'Public Domain, Exempt from Copyright', as appropriate)
Team
Standards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version
1.0(or higher as appropriate when doing a supplement revision)
Status
DRAFT(or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.
Date
yyyy-mm-dd(date current version released, regardless of status - this date should always match the date in the Revision History section below and should be updated every time this supplement is edited.)
Notes to Readers
This supplement is available 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.
This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (COA #XXX, Qualified Clinical Outcome Assessments (COA) | FDA)(Use only for instruments this applies to; update COA #.)
Known Issues
Only include this row to describe any known issues related to the supplement. If there are no issues, this row can be deleted.