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Info

title	Instructions on how to use this template

Info

title	Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

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	C-SSRS BASELINE
QRS Permission Status	Approved
Team	CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	1.3
Status	REVISION DRAFT
Date	20212022-0908-2211
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.)Model Implementation Guide for Human Clinical Trials.

Revision History

Date	Version	Summary of Changes
2021-09-22	1.3 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 "Since Last Visit" Added conditionally described items to a skipped item when it does not apply Variable QNAM=EVLINTTX replaced by QSEVINTX = LIFETIME. b. Added annotations for QSSTRESC/QSSTRESN wherever applicable Added the first assumption to include details on every item of the instrument. The QSEVAL and QSEVALID assumption and variables were 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 QSTESTCD = "CSS0222B" QSTEST = "CSS02-Most Lethal Attempt Damage" to indicate CRF Text over 200 characters Added example for SUPPQS dataset Added section 5 Supplemental Qualifier Name Codes.
2014-09-03	1.2	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised: 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	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

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