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titleInstructions on how to use this template
  1. ******ITEMS IN RED: Needs to be discussed with Team.*******
Info
titleInformation 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.

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Title

Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version (CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusREVISION DRAFT
Date2023-0304-2313
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.

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DateVersionSummary of Changes

2023-03-23

2.0
  • Converted the supplement to the current WIKI QRS supplement template.Annotated CRF updated to the MSG V2.0 annotation guidelines
  • Annotated CRF updated to the MSG V2.0 annotation guidelines
  • Copyright Status section was updated based on the latest Memorandum of Understanding signed between McMaster
    University and CDISC.
  • Reference for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION was updated to retain only the valid hyperlinks.
  • Updated the assumption to clarify that the CRQ-SAS First Administration consists of 20 items with each item graded on a 7-point or 8-point Likert scale.
  • Updated assumption 1.a to specify users need to follow the scoring solution in their approved copyright permission when the result is“8 = Not Done”.
  • Removed the QSEVAL assumption and variables as this is not captured on the CRF and no assumptions are made on potential values.
2015-02-181.0Initial Final Version

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The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is a multiple-choice instrument that clinicians may use to measure health-related quality of life (HRQL) in patients with chronic respiratory diseases.  It consists of 20 items with each item graded on a 7-point or 8-point Likert scale.

  1. The scale points include a numeric rating (1-7) and a definition of what is represented by the rating (e.g., 1 = "All of the time"). For the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
           a.  The first 5 questions have a questionnaire choice of “8 = Not Done”. The result of “8” is included in QSSTRESC and QSSTRESN; however, users need to follow the scoring Solution in their approved copyright permission.

  2. The time period of evaluation for theCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is populated in the QSEVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is the LAST 2 WEEKS (QSEVLINT = "-P2W").

  3. Records Records are created in qs.xpt for  for every collected item on the the instrument: 

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

    2. Due to the variability of copyright holder and public domain derived score generation processes, records are not included for derived subscores or total scores that are not provided.

  4. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

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