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Revision History

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

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1. Each of the 7 items is rated on a 5-point verbal rating scale

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   from either "No <symptom> at All" to "Very Severe <symptom>", or from "Never" to "Always" (depending on the item's question structure), relative to either intensity or frequency. For the NSCLC-SAQ V1.0, QSORRES is populated with the text description of the rating scale response chosen.  

2. No score is displayed for any item on the instrument in either the paper form or the electronic format; however, the user manual for the CRF includes the standardized representation of zero (e.g., "No Coughing at All”, “No Pain at All”, “Never”) through 4 (e.g., “Very Severe Coughing”, "Very Severe Pain", “Always”). Because (a) electronic administration is expected frequently, (b) instructions are provided in the user manual

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   for scoring from C-Path's PRO Consortium, and (c) the numeric score for each question is expected to be submitted with the data, CDISC will represent the standardized scores in QSSTRESC and QSSTRESN.

3. The time period of evaluation for the NSCLC-SAQ 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 NSCLC-SAQ V1.0 is the past 7 days.

4. If no response is provided for an item, then QSORRES, QSSTRESC, and QSSTRESN are all set to null and QSSTAT = “NOT DONE”.

5. A total score, ranging from 0-20, and 5 subscores, not collected on the NSCLC-SAQ V1.0 CRF but documented in the user manual, are considered as captured data and are not considered as derived in the example below.

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    These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from  user manual.

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL 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 (--DRVFL) is set to Y.

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      However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and

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      would be null (See SDTMIG Section: 4.1.8.1, Origin Metadata for Variables).

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

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6. 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

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