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1. The scale points include a text rating (e.g., "Not at all", "Slightly", etc.). 

   1. 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 QSEVINTX = "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. The E-RS (EXACT-Respiratory Symptoms)* USER MANUAL (Version 4.0) May 2015 that is provided upon user's receiving copyright permission provides information to calculate these items. The EXACT Total score is computed across the 14 items and has a theoretical range of 0 to 100. Subscores Subtotal 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 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. For these missing diary days, a records is created for each question with QSORRES, QSSTRESC and QSSTRESN are represented with missing values. QSSTAT = "NOT DONE" and QSREASND = "NO RESPONSE COLLECTED" to note that these records did not capture any data.

   1. “Presence of Data” items missing data rule:

      1. A record is created in qs.xpt for all items.
      2. If the reason for the not done record is known, then --STAT=“NOT DONE” and --REASND=reason provided (e.g., “PREFER NOT TO ANSWER”)
      3. If the reason for the not done record is unknown, then the reason is that the response was not collected (--STAT=“NOT DONE” and --REASND=“NO RESPONSE COLLECTED”)

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

   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 for 1 enenibg of data capture  evening of data capture and an additional evening in which no responses were captured on 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 also represented as the standard character representation in QSSTRESC.

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The table represents the items from the EXACT form. Rows 15 - 28 represent a day in whihc no resoonses were which no responses were collected, which is based on assumption 5 above.

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