...
| Page properties |
|---|
| Title | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) |
|---|
| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
|---|
| QRS Short Name | QRS Short_NameC-SSRS BASELINE |
|---|
| QRS Permission Status | Approved (or 'Public Domain', 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)3 |
|---|
| 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) |
|---|
| REVISION DRAFT | | Date | 2021-09-22 |
|---|
| Notes | 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.)
|
|---|
|
Revision History
| Date | Version | Summary of Changes |
|---|
| 2021- |
mmdd0 Draft| 3 Draft |
|
| 2014-09-03 | 1.2 | - Updated references to QSCAT and questionnaire name throughout the document.
- Section 3.1: Assumption # 2 – Evaluation Interval mapped to QSEVINTX (from EVLINTTX).
- Section 3.2: Updated text above example table. Example table updated to include QSEVINTX in the QS table. Removed the SUPPQS.xpt table.
- Section 4: (SDTM Mapping Strategy) for QSTESTCD=CSS0111
- Old value: Completely to end or stop pain
- New value: Completely to end or stop the pain
|
| 2013-02-06 | 1.1 | - QSSCAT added to be compatible with all CSSR-S questionnaires
- QSTPT replaced with QNAM=EVLINTTX to be compatible with all CSSR-S questionnaires using evaluation intervals
- Corrected “Dose not apply”, associated with the Most Severe Ideation, Reasons on page 9 to “Does not apply”.
- Added QS terminology reference
|
| 2012-08-07 | 1.0 Final | Initial Version |
© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
...