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This document describes the CDISC implementation of the Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) instrument.

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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CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.  CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument. 

2 Copyright Status

Critical Path Institute owns the copyright for the ADSD V1.0 instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements.  Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the questionnaire. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.instrument. 

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values .

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CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges the Critical Path Institute for the approval to include the ADSD V1.0 in the CDISC data standards.

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1. The scale points include a 0 to 10 rating with 0 = "None", 10 = "As bad as you can imagine", and all points in between only having a numeric value. For the ADSD V1.0, QSORRES is populated with the text description for "None" and "As bad as you can imagine" and the numeric value for all other answers, while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

2. The time period of evaluation for the ADSD V1.0 is populated in the QSEVINTXwhen the evaluation interval can be precisely described as duration. The evaluation interval for the ADSD V1.0 is since you got up this morning (QSEVINTX = "SINCE GETTING UP THIS MORNING").

3. A The ADSD V1.0 instrument includes a total score , that is not collected on the ADSD v1.0 CRF but which is described in the manual

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   , may be submitted as an Electronic Data Transfer (eDT) along with the individual item data for the ADSD 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 ADSD v1.0 total score is that 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

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      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. 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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The ADSD V1.0 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 the ADSD V1.0 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 the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

The table represents the items from the ADSD V1.0 form instrument as well as the total score. Rows 8-14 show how to represent data when the entire instrument was not done due to the subject refusing the test.

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