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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") as represented on the CRF.

3. The EXACT instrument includes CRF does not include subtotals or a totl score on th CRF total score on the CRF, but the copyright holder provides software to calculate these derived items. They may be provides These items may be provided as part of a total score (and other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the CRF and is 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. 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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The EXACT 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 for 1 enenibg of data capture the EXACT instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into also represented as the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

• "This example is based on a questionnaire with an evaluation interval of xxx." allows the QSEVLINT (or QSEVINTX) column to be removed from the example. Note that it was not used for the IDS-SR instrument used in the example below as it is not the same for all items.
• "This example is based on a questionnaire with an evaluation interval of the past week. QSLOBXFL is NULL based on VISITNUM = 2." saves space if there are a large number of columns.  If this statement is used, leave off the QSEVLINT, QSLOBXFL and VISITNUM columns in the example.
• "QSSTRESN is null as there are no standardized numeric results for this instrument."  This statement is used when there are no standardized numeric values.  The QSSTRESN column is then removed from the below example.

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QSTESTCD = "EXACT102" QSTEST = "EXACT1-How Often Cough"

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