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| Title | Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) |
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| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Approved |
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| Team | CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | Final |
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| Date | 2021-0509-2408 |
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| Notes | - This 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.
- This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument.
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Revision History
| Date | Version |
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| 2021-0509-2408 | 1.0 |
© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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The table represents the items from the ANSD V1.0 instrument as well as the total score. Rows 8-14 show how to represent data when the entire instrument was not done14 show the subject was not evaluated on this instrument at visit 1. Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSLOBXFL | VISITNUM | QSDTC | QSEVINTX |
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| 1 | STUDYX | QS | 2324-P0001 | 1 | ANSD0101 | ANSD01-Rate Breathing at Its Worst | ANSD V1.0 | 6 | 6 | 6 |
| Y | 1 | 2015-05-15 | | | 2 | STUDYX | QS | 2324-P0001 | 2 | ANSD0102 | ANSD01-Rate Wheezing at Its Worst | ANSD V1.0 | None | 0 | 0 |
| Y | 1 | 2015-05-15 | SINCE GOING TO BED | | 3 | STUDYX | QS | 2324-P0001 | 3 | ANSD0103 | ANSD01-Rate Shortness of Breath at Worst | ANSD V1.0 | 3 | 3 | 3 |
| Y | 1 | 2015-05-15 | SINCE GOING TO BED | | 4 | STUDYX | QS | 2324-P0001 | 4 | ANSD0104 | ANSD01-Rate Chest Tightness at Its Worst | ANSD V1.0 | 2 | 2 | 2 |
| Y | 1 | 2015-05-15 | SINCE GOING TO BED | | 5 | STUDYX | QS | 2324-P0001 | 5 | ANSD0105 | ANSD01-Rate Chest Pain at Its Worst | ANSD V1.0 | 5 | 5 | 5 |
| Y | 1 | 2015-05-15 | SINCE GOING TO BED | | 6 | STUDYX | QS | 2324-P0001 | 6 | ANSD0106 | ANSD01-Rate Cough at Its Worst | ANSD V1.0 | As bad as you can imagine | 10 | 10 |
| Y | 1 | 2015-05-15 | SINCE GOING TO BED | | 7 | STUDYX | QS | 2324-P0001 | 7 | ANSD0107 | ANSD01-Total Score | ANSD V1.0 | 4.3 | 4.3 | 4.3 |
| Y | 1 | 2015-05-15 | SINCE GOING TO BED | | 8 | STUDYX | QS | 2324-P0020 | 1 | ANSD0101 | ANSD01-Rate Breathing at Its Worst | ANSD V1.0 |
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| NOT DONE | Y |
| 1 | 2015-05-20 |
| | | 9 | STUDYX | QS | 2324-P0020 | 2 | ANSD0102 | ANSD01-Rate Wheezing at Its Worst | ANSD V1.0 |
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| NOT DONE | Y |
| 1 | 2015-05-20 |
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| | 10 | STUDYX | QS | 2324-P0020 | 3 | ANSD0103 | ANSD01-Rate Shortness of Breath at Worst | ANSD V1.0 |
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| NOT DONE | Y |
| 1 | 2015-05-20 |
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| | 11 | STUDYX | QS | 2324-P0020 | 4 | ANSD0104 | ANSD01-Rate Chest Tightness at Its Worst | ANSD V1.0 |
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| NOT DONE | Y |
| 1 | 2015-05-20 |
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| | 12 | STUDYX | QS | 2324-P0020 | 5 | ANSD0105 | ANSD01-Rate Chest Pain at Its Worst | ANSD V1.0 |
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| NOT DONE | Y |
| 1 | 2015-05-20 |
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| | 13 | STUDYX | QS | 2324-P0020 | 6 | ANSD0106 | ANSD01-Rate Cough at Its Worst | ANSD V1.0 |
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| NOT DONE | Y |
| 12015-05-20 |
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| | 14 | STUDYX | QS | 2324-P0020 | 7 | ANSD0107 | ANSD01-Total Score | ANSD V1.0 |
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| NOT DONE | Y |
| 12015-05-20 |
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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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