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Title

Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)

CDISC Reference

Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

ANSD V1.0

QRS Permission Status

Approved

Team

CDISC Questionnaires, Ratings, and Scales (QRS) Subteam

Supplement Version

1.0

Status

Final

Date

20212024-1202-0809

Notes

This supplement is available to be used with other CDISC user guides
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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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Revision History

Date	Version
20212024-1202-0809	1.0 Final

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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 ANSD 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.
The time period of evaluation
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for the ANSD V1.0 is populated in the QSEVINTX when the evaluation interval can be precisely described as duration. The evaluation interval for the ANSD V1.0 is, "since you went to bed last night" (QSEVINTX = "SINCE GOING TO BED").
The ANSD The ANSD V1.0 instrument includes a total 0 instrument includes an overall score
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that is considered is considered as captured data on the CRF instrument and is not considered as derived
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in the example below. These scores may be submitted in SDTM or
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derived in the Analysis Data Model (ADaM) per scoring instructions from the user manual.Critical Path Institute.
1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
2. If operationally defined by the sponsor,
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  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).
3. If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
4. If scores are received by the sponsor
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  , it is recommended that they are submitted to SDTM and verified in ADaM.
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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