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Title

Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)

CDISC ReferenceQuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

ADSD V1.0

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date20192020-0907-1015
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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Revision History

DateVersion
20192020-0907-10151.0 Draft

© 2019 2020 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) questionnaireinstrument.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this questionnaire instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this questionnaire 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/foundational/qrs.

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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 (ADSD Annotated CRF.pdf).  .

Info
titleInformation for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

 NoteNote: 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.

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

References for the Asthma Daytime Symptom Diary V1.0 (ADSD V1.0):

  • Version 1.0 Copyright 2015 Critical Path Institute. All Rights Reserved.
  • Gater A, Nelsen L, Fleming S, Lundy J.J, Bonner N, Hall R, Marshall C, Staunton H, Krishnan JA, Stoloff S, Schatz M, Haughney J on behalf of the Patient-Reported Outcome Consortium’s Asthma Working Group. Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the Asthma Daily Symptom Diary. Value in Health 2016; 9:440-450).

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