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Title Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) CDISC Reference Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials QRS Short Name ADSD V1.0 QRS Permission Status Approved Team CDISC Questionnaires, Ratings, and Scales (QRS) Subteam Supplement Version 1.0 Status Final Date 20212024-05-2409 Notes This supplement is intended available to be used with other CDISC user guides Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-649 for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials. This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (COA #000006, Qualified Clinical Outcome Assessments (COA) | FDA)

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© 2021 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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

CDISC does did not modify this questionnaires, ratings, and scales

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(QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols

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.  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

The Critical Path Institute

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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 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 .

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

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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The ADSD V1.0 is a 6-item patient diary PRO measure

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to assess self-reported severity of asthma symptoms during the day. Each item is rated on an 11-point numeric rating scale. A total An overall score is also represented as described in the manualdescribed in the manual. Please refer to the user manual for instructions on how to calculate the overall score.

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 QSEVINTX when the QSEVINTX as an evaluation interval can text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the ADSD V1.0 is 0 is, "since you got up this morning" (QSEVINTX = "SINCE GETTING UP THIS MORNING

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   ").

3. The ADSD The ADSD V1.0 instrument includes a total score that is considered 0 instrument includes a overall score

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   that is considered as captured data on the CRF instrument

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   and is not considered as derived in the example below. These scores may be submitted in SDTM or and

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   derived in the Analysis Data Model (ADaM) per  per scoring instructions from the user manual.
   1. The overall score is represented in--ORRES, --STRESC, and --STRESN.
   2. If the overall score is received or derived by 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 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).if scores are received by the sponsor, or derived by the sponsor,

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      it is recommended that they are submitted to SDTM and SDTM and verified in ADaM. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

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.

3.2 Example for the ADSD V1.0 QS Domain Model

The ADSD V1.0 example below shows the terminology used to implement the instrument

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in the QS domain. This example shows the self-reported data for 2 subjects collected at the baseline visit for the ADSD V1.0 instrument. VISITNUM in this data represents the day the subject reported data. The baseline visit is the first day they record data prior to any treatment. 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 instrument as instrument as well as the total overall score. Rows 8-14 show how to represent data when the entire instrument was not done.the subject was not evaluated on this instrument at visit 1. Since this is daily diary data, the date is known and is included in QSDTC for when the visit was planned.

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Dataset wrap
Name qs
Dataset2 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSSTAT QSLOBXFL VISITNUM QSDTC QSEVINTX 1 STUDYX QS 2324-P0001 1 ADSD0101 ADSD01-Rate Breathing at Its Worst ADSD V1.0 6 6 6 Y 1 2015-05-15 SINCE GETTING UP THIS MORNING 2 STUDYX QS 2324-P0001 2 ADSD0102 ADSD01-Rate Wheezing at Its Worst ADSD V1.0 None 0 0 Y 1 2015-05-15 SINCE GETTING UP THIS MORNING 3 STUDYX QS 2324-P0001 3 ADSD0103 ADSD01-Rate Shortness of Breath at Worst ADSD V1.0 3 3 3 Y 1 2015-05-15 SINCE GETTING UP THIS MORNING 4 STUDYX QS 2324-P0001 4 ADSD0104 ADSD01-Rate Chest Tightness at Its Worst ADSD V1.0 2 2 2 Y 1 2015-05-15 SINCE GETTING UP THIS MORNING 5 STUDYX QS 2324-P0001 5 ADSD0105 ADSD01-Rate Chest Pain at Its Worst ADSD V1.0 5 5 5 Y 1 2015-05-15 SINCE GETTING UP THIS MORNING 6 STUDYX QS 2324-P0001 6 ADSD0106 ADSD01-Rate Cough at Its Worst ADSD V1.0 As bad as you can imagine 10 10 Y 1 2015-05-15 SINCE GETTING UP THIS MORNING 7 STUDYX QS 2324-P0001 7 ADSD0107 ADSD01-Total Score Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-662 ADSD V1.0 4.3 Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-663 4.3 4.3 Y 1 2015-05-15 SINCE GETTING UP THIS MORNING 8 STUDYX QS 2324-P0020 1 ADSD0101 ADSD01-Rate Breathing at Its Worst ADSD V1.0 NOT DONEY 1 2015-05-2017 9 STUDYX QS 2324-P0020 2 ADSD0102 ADSD01-Rate Wheezing at Its Worst ADSD V1.0 NOT DONEY 1 2015-05-2017 10 STUDYX QS 2324-P0020 3 ADSD0103 ADSD01-Rate Shortness of Breath at Worst ADSD V1.0 NOT DONE Y 1 2015-05-2017 11 STUDYX QS 2324-P0020 4 ADSD0104 ADSD01-Rate Chest Tightness at Its Worst ADSD V1.0 NOT DONEY 1 2015-05-2017 12 STUDYX QS 2324-P0020 5 ADSD0105 ADSD01-Rate Chest Pain at Its Worst ADSD V1.0 NOT DONEY 1 2015-05-2017 13 STUDYX QS 2324-P0020 6 ADSD0106 ADSD01-Rate Cough at Its Worst ADSD V1.0 NOT DONE Y 1 2015-05-2017 14 STUDYX QS 2324-P0020 7 ADSD0107 ADSD01-Total Score ADSD V1.0 NOT DONEY 1 2015-05-2017

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

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