Versions Compared

Old Version 66

changes.mady.by.user Diane Corey

Saved on

compared with

New Version Current

changes.mady.by.user Diane Corey

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Page properties
Title

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

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

ANSD V1.0

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusFinal
Date20212024-1202-0809
Notes
  • This supplement is available to be used with other CDISC user guides
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyQRSSUPP-673
    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)

...

Revision History

DateVersion
20212024-1202-08091.0 Final

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

...

  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 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.

  2. The time period of evaluation
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyQRSSUPP-677
    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").

  3. The ANSD V1.0 instrument includes an overall score

    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyQRSSUPP-678
    that is considered as captured data on the instrument and is not considered as derived
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyQRSSUPP-679
    in the example below    . These scores may be submitted in SDTM or
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyQRSSUPP-680
    derived in the Analysis Data Model (ADaM)     per scoring instructions from Critical Path Institute.

    1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
    2. If subscores  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 repsonsibility responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
      Jira
      showSummaryfalse
      serverIssue Tracker (JIRA)
      serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
      keyQRSSUPP-682

  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.

...