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changes.mady.by.user Steve Kopko

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changes.mady.by.user Fariba Alipour

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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.
  • Change the title of the page as follows:
    1. Remove 'Copy of QRS Supplement Template - '.
    2. Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
    3. Change 'QRS Short_Name' 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 'QRS Short_Name' 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 questionnaire, change 'questionnaire' to 'clinical classification' or 'functional test' as appropriate.
  • 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
    titleInstructions on how to use this template
    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.


    Page properties


    Title

    Name of QRS instrument (QRS Short_NameKurtzke Functional System Scores (KFSS)

    CDISC ReferenceQuestionnaire (or 'Clinical Classification' or 'Functional Test', as appropriate) Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
    QRS Short Name

    QRS Short_NameKFSS

    QRS Permission StatusApproved (or 'Public Domain', as appropriate)Public Domain
    TeamTeamStandards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
    Supplement Version12.0 (or higher as appropriate when doing a supplement revision)
    StatusDRAFT (or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.REVISION DRAFT 
    Dateyyyy2020-mm-dd (date current version released, regardless of status)06-15
    NotesThis 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.


    ...

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

    Dataset wrap
    Namesuppqs


    QNAMQLABELQVAL
    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 ( e.g., SUBJECT VISIT)



    End of Document