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Comment: FDA statement removed for PR

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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 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.

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DateVersionSummary of Changes

2023-0304-2313

2.0
  • 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 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.
  • 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

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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 FOLLOW-UP 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.

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Dataset wrap
Nameqs
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011CRQ0201CRQ02-Feeling EmotionalCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONExtremely short of breath11
32022-05-15-P2W
2STUDYXQS2324-P00012CRQ0202CRQ02-Take Care of Basic NeedsCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONVery short of breath22
32022-05-15-P2W
3STUDYXQS2324-P00013CRQ0203CRQ02-WalkingCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONModerate shortness of breath44
32022-05-15-P2W
4STUDYXQS2324-P00014CRQ0204CRQ02-Performing ChoresCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONNot at all short of breath77
32022-05-15-P2W
5STUDYXQS2324-P00015CRQ0205CRQ02-Participate in Social ActivitiesCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONNot Done88
32022-05-15-P2W
6STUDYXQS2324-P00016CRQ0206CRQ02-Felt Frustrated or ImpatientCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONA good bit of the time33
32022-05-15-P2W
7STUDYXQS2324-P00017CRQ0207CRQ02-Feeling of Fear or PanicCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONSome of the time44
32022-05-15-P2W
8STUDYXQS2324-P00018CRQ0208CRQ02-FatigueCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONExtremely tired11
32022-05-15-P2W
9STUDYXQS2324-P00019CRQ0209CRQ02-Embarrassed by CoughingCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONA little of the time55
32022-05-15-P2W
10STUDYXQS2324-P000110CRQ0210CRQ02-Confident to Deal With IllnessCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONA little of the time22
32022-05-15-P2W
11STUDYXQS2324-P000111CRQ0211CRQ02-EnergyCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONFull of energy77
32022-05-15-P2W
12STUDYXQS2324-P000112CRQ0212CRQ02-Feel Upset, Worried or DepressedCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONHardly any of the time66
32022-05-15-P2W
13STUDYXQS2324-P000113CRQ0213CRQ02-Control of Breathing ProblemsCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONMost of the time55
32022-05-15-P2W
14STUDYXQS2324-P000114CRQ0214CRQ02-Feel Relaxed and Free of TensionCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONA good bit of the time44
32022-05-15-P2W
15STUDYXQS2324-P000115CRQ0215CRQ02-Felt Low in EnergyCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONA good bit of the time33
32022-05-15-P2W
16STUDYXQS2324-P000116CRQ0216CRQ02-Felt Discouraged or DownCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONMost of the time22
32022-05-15-P2W
17STUDYXQS2324-P000117CRQ0217CRQ02-Felt Worn Out or SluggishCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONAll of the time11
32022-05-15-P2W
18STUDYXQS2324-P000118CRQ0218CRQ02-Happy, Satisfied or PleasedCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONHappy most of the time55
32022-05-15-P2W
19STUDYXQS2324-P000119CRQ0219CRQ02-Feel Upset Diff Getting BreathCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONMost of the time22
32022-05-15-P2W
20STUDYXQS2324-P000120CRQ0220CRQ02-Felt Restless, Tense or UptightCRQ-SAS FOLLOW-UP ADMINISTRATION VERSIONSome of the time44
32022-05-15-P2W
21STUDYXQS2324-P000121CRQ0201CRQ02-Feeling EmotionalCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

22STUDYXQS2324-P000122CRQ0202CRQ02-Take Care of Basic NeedsCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

23STUDYXQS2324-P000123CRQ0203CRQ02-WalkingCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

24STUDYXQS2324-P000124CRQ0204CRQ02-Performing ChoresCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

25STUDYXQS2324-P000125CRQ0205CRQ02-Participate in Social ActivitiesCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

26STUDYXQS2324-P000126CRQ0206CRQ02-Felt Frustrated or ImpatientCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

27STUDYXQS2324-P000127CRQ0207CRQ02-Feeling of Fear or PanicCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

28STUDYXQS2324-P000128CRQ0208CRQ02-FatigueCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

29STUDYXQS2324-P000129CRQ0209CRQ02-Embarrassed by CoughingCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

30STUDYXQS2324-P000130CRQ0210CRQ02-Confident to Deal With IllnessCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

31STUDYXQS2324-P000131CRQ0211CRQ02-EnergyCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

32STUDYXQS2324-P000132CRQ0212CRQ02-Feel Upset, Worried or DepressedCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

33STUDYXQS2324-P000133CRQ0213CRQ02-Control of Breathing ProblemsCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

34STUDYXQS2324-P000134CRQ0214CRQ02-Feel Relaxed and Free of TensionCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

35STUDYXQS2324-P000135CRQ0215CRQ02-Felt Low in EnergyCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

36STUDYXQS2324-P000136CRQ0216CRQ02-Felt Discouraged or DownCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

37STUDYXQS2324-P000137CRQ0217CRQ02-Felt Worn Out or SluggishCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

38STUDYXQS2324-P000138CRQ0218CRQ02-Happy, Satisfied or PleasedCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

39STUDYXQS2324-P000139CRQ0219CRQ02-Feel Upset Diff Getting BreathCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

40STUDYXQS2324-P000140CRQ0220CRQ02-Felt Restless, Tense or UptightCRQ-SAS FOLLOW-UP ADMINISTRATION VERSION


NOT DONE4

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