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Green = Recent FDA Changes

Pink = Instructional information for developers

Blue = Text can change from supplement to supplement based on the instrument

Black = Standard template language

  1. Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
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titleInstructions on how to use this template
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titleInformation for Reviewers

Text in black is part of the template used to create this document and is not revised under CDISC internal or public 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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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.

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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 Stephen T Tiffany for the approval to include the QSU-BRIEF in the CDISC data standards.

References for the QSU-BRIEF:

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The QSU-BRIEF 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 QSU-BRIEF 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.

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The table represents the items from the QSU-BRIEF instrument.

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