Questionnaire (or 'Clinical Classification' or 'Functional Test', as appropriate) Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name
QRS Short_Name
QRS Permission Status
Approved(or 'Public Domain', as appropriate)
US FDA Qualified COA
Yes/No
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)
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.
This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (Use only for instruments this applies to.)