Versions Compared

Old Version 31

changes.mady.by.user Unknown User (ljoshua1)

Saved on

compared with

New Version Current

changes.mady.by.user Unknown User (ksmith)

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: FDA statement removed for PR

...

Page properties
Title

Chronic Respiratory Questionnaire - Self-Administered Standardized Format First Administration Version (CRQ-SAS FIRST ADMINISTRATION VERSION)

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

CRQ-SAS FIRST ADMINISTRATION VERSION

QRS Permission StatusApprovedAuthor Permission Required
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusREVISION DRAFT
Date2023-04-13
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.

...

DateVersionSummary of Changes
2023-0304-23132.0
  • Converted the supplement to the current WIKI QRS supplement template.
  • 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 FIRST 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.
  • The “QSBLFL” variable was replaced with the “QSLOBXFL” variable in the example to represent a baseline response for visit 1.
  • An additional subject was added to the data example to show how missing data is handled when the instrument was not completed.
2015-02-181.0Initial Final Version

...

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

McMaster University owns the copyright for the CRQ-SAS FIRST ADMINISTRATION VERSION instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. McMaster University will distribute the CDISC supplement package to sponsors when they are approved to use this instrument. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

The “Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS)”, authored by Drs. Gordon Guyatt and Holger Schünemann, was made under license from McMaster University, Hamilton, Canada (Copyright ©2001, McMaster University). The CRQ-SAS is provided under license from McMaster University and may not be copied, distributed or used in any way without the prior written consent of McMaster University. Contact the McMaster Industry Liaison Office at: milo@mcmaster.ca for licensing details.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

...