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DateVersionSummary of Changes
2019-12-021.1 Revision Draft
  • Converted the supplement to the current WIKI QRS supplement template.
  • Added the assumption 2 on using the QSEVINTX variable and added it to the example.
  • Added the assumption 3 on the inclusion of subtotal and total scores as Electronic Data Transfer (eDT). Need to review with Dana to potentially add these a new tests
  • Added assumption 5 regarding the need for a record of reach day of the study.
  • The QSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
2016-03-241.0

Final - Updated per Evidera instructions.  They have trademarked the EXACT® and updated the name of the E-RS™: COPD.

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The Evaluating Respiratory Symptoms (E-RS™) in COPD (E-RS™: COPD) scale is part of the EXACT instrument.  It is comprised of 11 items (of the 14-item EXACT) which provide information specific to respiratory symptoms in stable COPD. The E-RS: COPD is not administered separately from the EXACT.  For this reason, a separate SDTM questionnaire supplement for the E-RS: COPD will not be developed. Instructions for scoring the EXACT and E-RS: COPD, done during analysis of a clinical trial, can be found in the user manuals provided from the copyright holder when copyright use permission is obtained. Both measures will have ADaM QRS Supplements explaining the scoring and total of the results based on the user manual.


CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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  1. The scale points include a text rating (e.g., "Not at all", "Slightly", etc.). The E-RS (EXACT-Respiratory Symptoms)* USER MANUAL (Version 4.0) May 2015 that is provided upon user's receiving copyright permission provides the numeric scoring of the responses for the questions. Based on this being copyrighted, the numeric scores cannot be provided in this supplement. Upon receiving permission, sponsors may apply these numeric responses in their SDTM and ADaM datasets.  For this EXACT supplement, QSORRES and QSSTRESC is populated with the text description while the numeric rating is represented as missing in QSSTRESN.

  2. The time period of evaluation for the EXACT is populated in the QSEVINTX field. The evaluation interval for the EXACT is the past 7 days (QSEVLINT = "EVERY EVENING BEFORE BEDTIME") as represented on the CRF.

  3. The EXACT instrument CRF does not include subtotals or a total score on the CRF, but the copyright holder provides information in a user manual to calculate these derived items. These items. The EXACT Total score is computed across the 14 items and has a theoretical range of 0 to 100. Subscores scores are also computed for: Breathlessness, Cough & Sputum, and Chest Symptoms. These subscores also range from 0 to 100. These items may be provided as part of Electronic Data Transfer (eDT) that are considered as captured data and 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 --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

  4. VISITNUM is null at the time of publication of this document until CDISC develops guidance on how to consistently model timing information for daily diary instruments.
    1. The QSDTC variable contains the date/time the EXACT was completed by the subject and is used for the timing of this measure.
  5. Where no diary entry exists for a given day, create a record in the data file for that day. Each day a patient is followed in the study must have a record for the day.

  6. Terminology

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

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

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