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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 QRS Short_Name instrument and has granted CDISC permission to include this supplement in the CDISC library 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 questionnaire. (For public domain instruments, add: )There may be many versions of this instrument in the public domain or copyrightedthis instrument. CDISC has chosen to use this version as the data standard.

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

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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 the reference is the instrument itself, see if there is a reference available that could be used in addition to the CDISC Controlled Terminology reference.

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

References for the Title:

  • 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")

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