...
| Page properties |
|---|
| Title | Columbia-Suicide Severity Rating Scale Baseline Version 1/14/2009 (C-SSRS BASELINE) |
|---|
| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
|---|
| QRS Short Name | |
|---|
| QRS Permission Status | Approved |
|---|
| Team | CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
|---|
| Supplement Version | 2.0 |
|---|
| Status | REVISION DRAFT |
|---|
| Date | 20222023-0809-1126 |
|---|
| 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.
|
|---|
|
...
| Date | Version | Summary of Changes |
|---|
| 2022-0809-2226 | 2.0 Draft | - Converted the supplement to the current WIKI QRS supplement template.
- Annotated CRF updated to the MSG V2.0 annotation guidelines, including following updates:
a. Change of QSEVLINT to QSEVINTX for the Evaluation Interval Text of "LIFETIME" b. Added annotations for QSSTRESC/QSSTRESN wherever applicable - Added the first assumption to include details on every item of the instrument.
- The QSEVAL assumption and variable was removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values.
- Added assumptions 4, 5 and 6 for conditional branching. The example was updated to include records for these items.
- Added QSLOBXFL variable to the example to represent a baseline response for visit 1
- Added example to represent skipped visit (VISITNUM = 2)
- Added QSDRVFL variable to the example to represent items not done due to conditional branching.
- Section 4 (SDTM mapping strategy): Added an additional column in the table for "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt" (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B") to indicate CRF Text over 200 characters
- Added example for SUPPQS dataset
- Added section 5 Supplemental Qualifier Name Codes.
|
| 2014-09-03 | 1.2 | |
| 2013-02-06 | 1.1 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised: - 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 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Released |
| 2012-03-03 | 0.1 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Draft |
© 2021 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
...
This document describes the CDISC implementation of the Columbia-Suicide Severity Rating Scale Baseline Version 1/14/2009 (C-SSRS BASELINE) instrument.
...
Reference for the C-SSRS BASELINE:
- (C-SSRS) Since Last Visit Version 1/14/2009 (Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; Burke, A.; Oquendo, M.; Mann, J.; copyright 2008 The Research Foundation for Mental Hygiene, Inc.)
- No part of the C-SSRS SINCE LAST VISIT Version 1/14/2009 may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of The Research Foundation for Mental Hygiene, Inc. and payment of any applicable fees. Copyright 2008 The Research Foundation for Mental Hygiene, Inc. All rights reserved.
3 The QS Domain Model
3.1 Assumptions for the QS Domain Model
...