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  1. Respondents respond to each of the 7 items using 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. In most cases, the NSCLC-SAQ V1.0 will be administered electronically. No score is displayed for any item on the questionnaire in either the paper form or the electronic format; however, the user manual for the CRF includes the standardized representation of 0 (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 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. A total score ranging from 0-20, not collected on the NSCLC-SAQ V1.0 CRF, may be submitted as an Electronic Data Transfer (eDT) along with the individual item data for the NSCLC-SAQ V1.0. This original result will be recorded in QSORRES and a standardized representation of the score will be populated in QSSTRESC and QSSTRESN when it is included. The NSCLC-SAQ V1.0 total score is considered as captured data on the CRF and is not considered as derived in the example below.

    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 written on a CRF 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. However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and QSDRVFL would be null (See SDTMIG Section: 4.1.8.1, Origin Metadata for Variables).

  5. Subscores for the NSCLC-SAQ V1.0 concept domains (e.g., cough) will be derived in the Analysis Data Model (ADaM).

  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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