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titleInstructions on how to use this templateInformation 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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  • Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.
  • The text "–" in this template represents the domain implemented for the instrument. This is replaced with the 2-character domain abbreviation of FT, QS, or RS that is used for the instrument.
  • Change the title of the page as follows:
  • Remove 'Copy of QRS Supplement Template - '.
  • Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
  • Change '
    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

    ' to the short name (--CAT) for the current instrument.
  • Update the information in the Page Properties block below as indicated in the block below.
    1. The supplement version number will be 'v1' if there has never been a supplement for the instrument before. Otherwise, increment as appropriate.
    2. If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
  • Replace 'Title' and 'CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION' throughout the document with the title and short name of the instrument that the supplement is being created for.
  • Replace royal blue text with information pertaining to the instrument the supplement is being created for. Delete royal blue text which does not apply to the new instrument.
  • Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted.
  • Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate. Also when discussing the instrument as a general rule refer to it as instrument.
  • Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
  • Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.
  • Arabic numerals (0, 1, 2, 3, etc.)are used to express numbers in most circumstances. Exceptions are the following: 
    • Numbers that begin a sentence, title, subtitle, or heading 
    • Common fractions 

    • Accepted usage such as idiomatic expressions and numbers used as pronouns 

    • Other uses of “one” in running text (e.g., when meaning "a")
    • Ordinals first through ninth
    • Numbers spelled out in quotes or published titles.
    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.

    ...

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

    ...

    CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION

    ...

    • 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.)

    Revision History

    ...

    © 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

    ...

    For the first version of a supplement, use the above Revision History table and delete this information box.

    When a previously published supplement is being revised, a modified "Revision History" table will need to be used. Add a new column at the right called "Summary of Changes" if this is the first revision to the supplement (see table below). Also add a new row under the column headers with the current information, keeping all rows previously added. The bottom row should be for Version 1.0, with subsequent versions added above each of the previous rows.

    If you are making changes to a supplement for the first time, put "Initial Final Version" in the Summary of Changes column for Version 1.0. Then add a row above with the new version number (1.1 if the changes are considered minor such as a typo, 2.0 if they are major such as variable changes) and summary of changes.

    Revision History

    ...

    © 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

    1 Introduction

    This document describes the CDISC implementation of the Title instrument.

    For CRFs that are NOT created by CDISC, use this statement:  CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

    For CRFs that are created by CDISC with SME input, use this statement:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on input from PASI (TA or instrument) subject matter experts. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.)

    For CRFs that created by CDISC based on articles, use this statement. Include the 1st sentence for articles that don't have a CRF.  If the 1st sentence is NOT included, then spell out "case report form (CRF)" in the 2nd sentence:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.)

    The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

    These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS (spell out "questionnaires, ratings, and scales" if this is a CDISC-created CRF and put QRS in parentheses.) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

    The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

    1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

    This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

    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 implement 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.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

    2 Copyright Status

    For copyrighted instruments use the following text:  Name of copyright holder (e.g., Board of Regents of The University of Texas System) 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. (For supplements that are to be distributed by the copyright holder, add: Name of copyright holder (e.g., Board of Regents of The University of Texas System) 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.

    For public domain instruments use the following text: CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

    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. 

    Info
    titleInformation for Reviewers

    The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

    Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

    Info

    Include the following statements as standalone paragraphs for copyrighted instruments:

    CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

    CDISC acknowledges [insert the name of the copyright holder, in blue text] (e.g., Dr. A. J. Rush, at the UT Southwestern Medical Center) for the approval to include the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION in the CDISC data standards.

    Reference for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION:

    Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000. 

    Info

    This is an example only.  Use the reference from the CDISC definition of the --CAT.

    • do not include the parentheses.
    • do not include copyright information from the definition about copyright holder and version since that's already included above.
    • do add a period to the end. 

    If there are multiple references, please use the following format:

    References for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION:

    • CDISC Controlled Terminology reference.
    • additional reference.
    Info

    Notes on the use of quotation marks:

    • Use for text values of a Likert scale: e.g., ...with response options ranging from “never” to “daily."
    • Actual numbers of the scale (e.g., 0-3) do not appear in quotation marks while the definitions of these anchors (e.g., 5 = “I always fall asleep”) do.
    • Enclose values for variables within quotation marks (e.g., QSTESTCD = "IPA0102")

    3 The QS Domain Model

    3.1 Assumptions for the QS Domain Model

    All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION are listed below.

    The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION is a multiple-choice instrument that clinicians may use to assess the severity of depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.

    ...

    Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). 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. (replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.

    Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes. The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: 

    ...

    Records are created in qs.xpt for every item on 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.

    ...

    If the instrument standards currently being developed includes logically skipped items, insert:  Some items on the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

    1. RSSTAT = "NOT DONE".       

    2. RSREASND = "LOGICALLY SKIPPED ITEM".

    3. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).

    ...

    Include this point if score(s) are submitted to SDTM. Update blue text: The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument includes a total score (and other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the CRF and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

    1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the QSDRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (QSDRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and QSDRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables). Subtotal and total scores are represented in QSORRES.

    2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.

    ...

    This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. instruments will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for instruments is currently under review. Remove this point if it does not apply.

    For Clinical Classifications and Functional Tests (only when collected on the CRF):  *** This section to be updated.  QSEVAL/ID, FTEVAL/ID, and RSEVAL/ID will no longer be used.  Supplemental qualifiers will represent this information. *** For CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.

    ...

    Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

    ...

    Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.

    ...

    Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN (and other variables such as QSORRESU as needed; only include QSORRES, QSSTRESC, and QSSTRESN if the responses are published in CT with public domains instruments) values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, resultand unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

    QRS Permission StatusAuthor 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.


    Revision History

    DateVersionSummary of Changes

    2023-04-13

    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

    © 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

    1 Introduction

    This document describes the CDISC implementation of the Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version instrument.

    CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

    The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

    These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

    The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

    1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

    This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

    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.

    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.

    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. 

    Info
    titleInformation for Reviewers

    The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

    Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

    CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

    CDISC acknowledges Gay Yuyitung, Executive Director, McMaster University, Hamilton, Ontario, Canada for the approval to include the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION in the CDISC data standards.

    Reference for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION:

    3 The QS Domain Model

    3.1 Assumptions for the QS Domain Model

    All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION are listed below.

    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 are created in qs.xpt for every collected item on 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.

    3.2 Example for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION QS Domain Model

    The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at visit 3 and visit 4 for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCATAll original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.


    Info

    We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


    The table represents the items from the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument. Rows 21-40 show the subject was not evaluated on this instrument at visit 4. A record for each item on the instrument is created with a status of "NOT DONE". Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. 

    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

    3.2 Example for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION QS Domain Model

    The CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCATAll original results, matching the CRF item response text, are represented in QSORRES. When there are numeric results, then use this sentence next, "This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument."

    ...

    Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

    For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

    ...

    When the reason is collected for a not done visit, information or a row description should be added as follows:

    ...

    Info

    We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

    ...

    Dataset wrap
    Nameqs
    Rowcaps
    Rows 13-14:Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".
    Rows 15-16:Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
    Row 33:The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF.
    Dataset2
    RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSLOBXFLVISITNUMQSDTCQSEVLINT
    1STUDYXQS2324-P00011IDSR101IDSR1-Falling AsleepIDS-SRI never take longer than 30 minutes to fall asleep00Y12015-05-15-P7D
    2STUDYXQS2324-P00012IDSR102IDSR1-Sleep During the NightIDS-SRI do not wake up at night00Y12015-05-15-P7D
    3STUDYXQS2324-P00013IDSR103IDSR1-Waking Up Too EarlyIDS-SRMost of the time, I awaken no more than 30 minutes before I need to get up00Y12015-05-15-P7D
    4STUDYXQS2324-P00014IDSR104IDSR1-Sleeping Too MuchIDS-SRI sleep no longer than 7-8 hours/night, without napping during the day00Y12015-05-15-P7D
    5STUDYXQS2324-P00015IDSR105IDSR1-Feeling SadIDS-SRI feel sad less than half the time11Y12015-05-15-P7D
    6STUDYXQS2324-P00016IDSR106IDSR1- Feeling IrritableIDS-SRI feel irritable less than half the time11Y12015-05-15-P7D
    7STUDYXQS2324-P00017IDSR107IDSR1-Feeling Anxious or TenseIDS-SRI feel anxious (tense) less than half the time11Y12015-05-15-P7D
    8STUDYXQS2324-P00018IDSR108IDSR1-Your Mood to Good/Desired EventsIDS-SRMy mood brightens but I do not feel like my normal self when good events occur11Y12015-05-15-P7D
    9STUDYXQS2324-P00019IDSR109IDSR1-Mood in Relation to Time of DayIDS-SRMy mood often relates to the time of day because of environmental events (e.g., being alone, working)11Y12015-05-15-P7D
    10STUDYXQS2324-P000110IDSR109AIDSR1-Mood Worse Morn/Afternoon/NightIDS-SRAfternoonAfternoonY12015-05-15-P7DRows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.)33STUDYXQS2324-P000133IDSR131IDSR1-ScoreIDS-SR181818Y12015-05-15
    Info

    The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

    Text that would remain unchanged has been left in black:

    The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

    Dataset wrap
    Namesuppqs
    STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
    STUDYXQSP0001QSSEQSequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM variable ( e.g., SUBJECT VISIT)CRF


    4 SDTM Mapping Strategy

    This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

    Info

    Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

    If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

    Some example mappings are below.

    ...

    For QRS instruments with subcategories:

    When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

    QSSCAT alignment with QSTESTCD

    As stated in Section 3.1 assumptions, items on the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

    ...

    Info
    titleFor public domain instrument's published QRS responses
    • If this is a public domain instrument that has an individual item with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

      • The controlled response terminology for the tests below is named --TESTCDOR for the variable RSORRES and --TESTCDSTR for the variables RSSTRESN and RSSTTRESC.

    • If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.
      • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

    ...

    If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

    "All QSTESTCDs"

    ...

    Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

    , and QSSTRESN) should be populated.


    QSTESTCD = "CRQ0201" QSTEST = "CRQ02-Feeling Emotional"

    QSTESTCD = "CRQ0202" QSTEST = "CRQ02-Take Care of Basic Needs"

    QSTESTCD = "CRQ0203" QSTEST = "CRQ02-Walking"

    QSTESTCD = "CRQ0204" QSTEST = "CRQ02-Performing Chores"

    QSTESTCD = "CRQ0205" QSTEST = "CRQ02-Participate in Social Activities"

    QSORRES

    QSSTRESC

    QSSTRESN

    Extremely short of breath11
    Very short of breath22
    Quite a bit short of breath33
    Moderate shortness of breath44
    Some shortness of breath55
    A little shortness of breath66
    Not at all short of breath77
    Not Done88

    QSTESTCD = "CRQ0206" QSTEST = "CRQ02-Felt Frustrated or Impatient"

    QSTESTCD = "CRQ0207" QSTEST = "CRQ02-Feeling of Fear or Panic"

    QSTESTCD = "CRQ0209" QSTEST = "CRQ02-Embarrassed by Coughing"

    QSTESTCD = "CRQ0212" QSTEST = "CRQ02-Feel Upset, Worried or Depressed"

    QSTESTCD = "CRQ0215" QSTEST = "CRQ02-Felt Low in Energy"

    QSTESTCD = "CRQ0216" QSTEST = "CRQ02-Felt Discouraged or Down"

    QSTESTCD = "CRQ0217" QSTEST = "CRQ02-Felt Worn Out or Sluggish"

    QSTESTCD = "CRQ0219" QSTEST = "CRQ02-Feel Upset Diff Getting Breath"

    QSTESTCD = "CRQ0220" QSTEST = "CRQ02-Felt Restless, Tense or Uptight"

    QSORRES

    QSSTRESC

    QSSTRESN

    All of the time11
    Most of the time22
    A good bit of the time33
    Some of the time44
    A little of the time55
    Hardly any of the time66
    None of the time77

    QSTESTCD = "CRQ0208" QSTEST = "CRQ02-Fatigue"

    QSORRES

    QSSTRESC

    QSSTRESN

    Extremely tired11
    Very tired22
    Quite a bit of tiredness33
    Moderately tired44
    Somewhat tired55
    A little tired66
    Not at all tired77

    QSTESTCD = "CRQ0210" QSTEST = "CRQ02-Confident to Deal With Illness"

    QSTESTCD = "CRQ0213" QSTEST = "CRQ02-Control of Breathing Problems"

    QSTESTCD = "CRQ0214" QSTEST = "CRQ02-Feel Relaxed and Free of Tension"

    QSORRES

    QSSTRESC

    QSSTRESN

    None of the time11
    A little of the time22
    Some of the time33
    A good bit of the time44
    Most of the time55
    Almost all of the time66
    All of the time77

    QSTESTCD = "CRQ0211" QSTEST = "CRQ02-Energy"

    QSORRES

    QSSTRESC

    QSSTRESN

    No energy at all11
    A little energy22
    Some energy33
    Moderately energetic44
    Quite a bit of energy55
    Very energetic66
    Full of energy77

    QSTESTCD = "CRQ0218" QSTEST = "CRQ02-Happy, Satisfied or Pleased"

    QSORRES

    QSSTRESC

    QSSTRESN

    Very dissatisfied, unhappy most of the time11
    Generally dissatisfied, unhappy22
    Somewhat dissatisfied, unhappy33
    Generally satisfied, pleased44
    Happy most of the time55
    Very happy most of the time66
    Extremely happy, could not be more satisfied or pleased77
    Info
    titleFor public domain instrument's published QRS responses

    If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. This approach used the CDISC QRS CT instrument's SYNONYM as part of the codelist name.

    The controlled response terminology for the tests below is named SYNONYMSET1OR for the variable RSORRES and SYNONYMSET1STR for the variables RSSTRESN and RSSTTRESC.

    ...

    If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

    QSTESTCD = "test code 1" QSTEST = "test name 1"

    QSTESTCD = "test code 4" QSTEST = "test name 4"

    QSTESTCD = "test code 5" QSTEST = "test name 5"

    QSTESTCD = "test code 6" QSTEST = "test name 6"

    QSTESTCD = "test code 7" QSTEST = "test name 7"

    QSTESTCD = "test code 8" QSTEST = "test name 8"

    QSTESTCD = "test code 15" QSTEST = "test name 15"

    QSTESTCD = "test code 22" QSTEST = "test name 22"

    QSTESTCD = "test code 27" QSTEST = "test name 27"

    QSTESTCD = "test code 29" QSTEST = "test name 29"

    ...

    Omit the QSSTRESN column when it is not applicable to the dataset.

    QSTESTCD = "test code" QSTEST = "test name"

    ...

    Info
    titleFor public domain instrument's published QRS responses

    If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

      • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

    ...

    For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

    QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

    QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

    ...

    5 Supplemental Qualifier Name Codes

    Info

    The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

    Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

    Remove Section 5 if it does not apply to the new instrument.

    The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

    ...

    Namesuppqs

    ...


    End of Document