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Revision History

© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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.

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

EORTC owns the copyright for the EORTC QLQ-C15-PAL V1.0 instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. EORTC 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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The EORTC QLQ-C15-PAL V1.0 is a multiple-choice instrument that that clinicians may use to assess the quality of life of palliative cancer care subjects. It consists of 14 items, each rated on a 4-point Likert scale, plus 1 item rated on a 7-point numeric rating scale.

1. The scale points include a 4-point Likert scale (1-4) and a 7-point numeric rating (1-7) and , with a definition of what is represented by the rating (e.g., 1 = "Not at all"). For the EORTC QLQ-C15-PAL V1.0, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

2.  The time period of evaluation for the EORTC QLQ-C15-PAL V1.0 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the EORTC QLQ-C15-PAL V1.0 is the past week for QSTESTCD="EOR0204" thru "EOR0215".

3. Terminology

   1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

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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.

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