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Title | Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version (CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION) |
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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 | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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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 | 2.0 |
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Status | REVISION DRAFT |
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Date | 2023-03-1423 |
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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.
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Date | Version | Summary of Changes |
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2023-03- 1423 | 2.0 | - Converted the supplement to the current WIKI QRS supplement template.
- Annotated CRF updated to the MSG V2.0 annotation guidelines
- Removed the QSEVAL assumption and variables as this is not captured on the CRF and no assumptions are made on potential values.
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2015-02-18 | 1.0 | Initial Final Version |
© 2022 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.
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Dataset wrap |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | VISITNUM | QSDTC | QSEVLINT |
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1 | STUDYX | QS | 2324-P0001 | 1 | CRQ0201 | CRQ02-Feeling Emotional | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Extremely short of breath | 1 | 1 |
| 3 | 2022-05-15 | -P2W | 2 | STUDYX | QS | 2324-P0001 | 2 | CRQ0202 | CRQ02-Take Care of Basic Needs | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Very short of breath | 2 | 2 |
| 3 | 2022-05-15 | -P2W | 3 | STUDYX | QS | 2324-P0001 | 3 | CRQ0203 | CRQ02-Walking | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Moderate shortness of breath | 4 | 4 |
| 3 | 2022-05-15 | -P2W | 4 | STUDYX | QS | 2324-P0001 | 4 | CRQ0204 | CRQ02-Performing Chores | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Not at all short of breath | 7 | 7 |
| 3 | 2022-05-15 | -P2W | 5 | STUDYX | QS | 2324-P0001 | 5 | CRQ0205 | CRQ02-Participate in Social Activities | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Not Done | 8 | 8 |
| 3 | 2022-05-15 | -P2W | 6 | STUDYX | QS | 2324-P0001 | 6 | CRQ0206 | CRQ02-Felt Frustrated or Impatient | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | A good bit of the time | 3 | 3 |
| 3 | 2022-05-15 | -P2W | 7 | STUDYX | QS | 2324-P0001 | 7 | CRQ0207 | CRQ02-Feeling of Fear or Panic | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Some of the time | 4 | 4 |
| 3 | 2022-05-15 | -P2W | 8 | STUDYX | QS | 2324-P0001 | 8 | CRQ0208 | CRQ02-Fatigue | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Extremely tired | 1 | 1 |
| 3 | 2022-05-15 | -P2W | 9 | STUDYX | QS | 2324-P0001 | 9 | CRQ0209 | CRQ02-Embarrassed by Coughing | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | A little of the time | 5 | 5 |
| 3 | 2022-05-15 | -P2W | 10 | STUDYX | QS | 2324-P0001 | 10 | CRQ0210 | CRQ02-Confident to Deal With Illness | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | A little of the time | 2 | 2 |
| 3 | 2022-05-15 | -P2W | 11 | STUDYX | QS | 2324-P0001 | 11 | CRQ0211 | CRQ02-Energy | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Full of energy | 7 | 7 |
| 3 | 2022-05-15 | -P2W | 12 | STUDYX | QS | 2324-P0001 | 12 | CRQ0212 | CRQ02-Feel Upset, Worried or Depressed | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Hardly any of the time | 6 | 6 |
| 3 | 2022-05-15 | -P2W | 13 | STUDYX | QS | 2324-P0001 | 13 | CRQ0213 | CRQ02-Control of Breathing Problems | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Most of the time | 5 | 5 |
| 3 | 2022-05-15 | -P2W | 14 | STUDYX | QS | 2324-P0001 | 14 | CRQ0214 | CRQ02-Feel Relaxed and Free of Tension | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | A good bit of the time | 4 | 4 |
| 3 | 2022-05-15 | -P2W | 15 | STUDYX | QS | 2324-P0001 | 15 | CRQ0215 | CRQ02-Felt Low in Energy | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | A good bit of the time | 3 | 3 |
| 3 | 2022-05-15 | -P2W | 16 | STUDYX | QS | 2324-P0001 | 16 | CRQ0216 | CRQ02-Felt Discouraged or Down | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Most of the time | 2 | 2 |
| 3 | 2022-05-15 | -P2W | 17 | STUDYX | QS | 2324-P0001 | 17 | CRQ0217 | CRQ02-Felt Worn Out or Sluggish | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | All of the time | 1 | 1 |
| 3 | 2022-05-15 | -P2W | 18 | STUDYX | QS | 2324-P0001 | 18 | CRQ0218 | CRQ02-Happy, Satisfied or Pleased | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Happy most of the time | 5 | 5 |
| 3 | 2022-05-15 | -P2W | 19 | STUDYX | QS | 2324-P0001 | 19 | CRQ0219 | CRQ02-Feel Upset Diff Getting Breath | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Most of the time | 2 | 2 |
| 3 | 2022-05-15 | -P2W | 20 | STUDYX | QS | 2324-P0001 | 20 | CRQ0220 | CRQ02-Felt Restless, Tense or Uptight | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | Some of the time | 4 | 4 |
| 3 | 2022-05-15 | -P2W | 21 | STUDYX | QS | 2324-P0001 | 21 | CRQ0201 | CRQ02-Feeling Emotional | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 22 | STUDYX | QS | 2324-P0001 | 22 | CRQ0202 | CRQ02-Take Care of Basic Needs | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 23 | STUDYX | QS | 2324-P0001 | 23 | CRQ0203 | CRQ02-Walking | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 24 | STUDYX | QS | 2324-P0001 | 24 | CRQ0204 | CRQ02-Performing Chores | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 25 | STUDYX | QS | 2324-P0001 | 25 | CRQ0205 | CRQ02-Participate in Social Activities | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 26 | STUDYX | QS | 2324-P0001 | 26 | CRQ0206 | CRQ02-Felt Frustrated or Impatient | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 27 | STUDYX | QS | 2324-P0001 | 27 | CRQ0207 | CRQ02-Feeling of Fear or Panic | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 28 | STUDYX | QS | 2324-P0001 | 28 | CRQ0208 | CRQ02-Fatigue | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 29 | STUDYX | QS | 2324-P0001 | 29 | CRQ0209 | CRQ02-Embarrassed by Coughing | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 30 | STUDYX | QS | 2324-P0001 | 30 | CRQ0210 | CRQ02-Confident to Deal With Illness | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 31 | STUDYX | QS | 2324-P0001 | 31 | CRQ0211 | CRQ02-Energy | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 32 | STUDYX | QS | 2324-P0001 | 32 | CRQ0212 | CRQ02-Feel Upset, Worried or Depressed | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 33 | STUDYX | QS | 2324-P0001 | 33 | CRQ0213 | CRQ02-Control of Breathing Problems | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 34 | STUDYX | QS | 2324-P0001 | 34 | CRQ0214 | CRQ02-Feel Relaxed and Free of Tension | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 35 | STUDYX | QS | 2324-P0001 | 35 | CRQ0215 | CRQ02-Felt Low in Energy | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4 | -P2W |
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| 36 | STUDYX | QS | 2324-P0001 | 36 | CRQ0216 | CRQ02-Felt Discouraged or Down | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 37 | STUDYX | QS | 2324-P0001 | 37 | CRQ0217 | CRQ02-Felt Worn Out or Sluggish | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 38 | STUDYX | QS | 2324-P0001 | 38 | CRQ0218 | CRQ02-Happy, Satisfied or Pleased | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 39 | STUDYX | QS | 2324-P0001 | 39 | CRQ0219 | CRQ02-Feel Upset Diff Getting Breath | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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| 40 | STUDYX | QS | 2324-P0001 | 40 | CRQ0220 | CRQ02-Felt Restless, Tense or Uptight | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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| NOT DONE | 4-P2W |
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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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QSTESTCD = "CRQ0205" QSTEST = "CRQ02-Participate in Social Activities"
QSORRES | QSSTRESC | QSSTRESN |
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Extremely short of breath | 1 | 1 |
Very short of breath | 2 | 2 |
Quite a bit short of breath | 3 | 3 |
Moderate shortness of breath | 4 | 4 |
Some shortness of breath | 5 | 5 |
A little shortness of breath | 6 | 6 |
Not at all short of breath | 7 | 7 |
Not Done | 8 | 8 |
QSTESTCD = "CRQ0206" QSTEST = "CRQ02-Felt Frustrated or Impatient"
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QSTESTCD = "CRQ0220" QSTEST = "CRQ02-Felt Restless, Tense or Uptight"
QSORRES | QSSTRESC | QSSTRESN |
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All of the time | 1 | 1 |
Most of the time | 2 | 2 |
A good bit of the time | 3 | 3 |
Some of the time | 4 | 4 |
A little of the time | 5 | 5 |
Hardly any of the time | 6 | 6 |
None of the time | 7 | 7 |
QSTESTCD = "CRQ0208" QSTEST = "CRQ02-Fatigue"
QSORRES | QSSTRESC | QSSTRESN |
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Extremely tired | 1 | 1 |
Very tired | 2 | 2 |
Quite a bit of tiredness | 3 | 3 |
Moderately tired | 4 | 4 |
Somewhat tired | 5 | 5 |
A little tired | 6 | 6 |
Not at all tired | 7 | 7 |
QSTESTCD = "CRQ0210" QSTEST = "CRQ02-Confident to Deal With Illness"
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QSTESTCD = "CRQ0214" QSTEST = "CRQ02-Feel Relaxed and Free of Tension"
QSORRES | QSSTRESC | QSSTRESN |
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None of the time | 1 | 1 |
A little of the time | 2 | 2 |
Some of the time | 3 | 3 |
A good bit of the time | 4 | 4 |
Most of the time | 5 | 5 |
Almost all of the time | 6 | 6 |
All of the time | 7 | 7 |
QSTESTCD = "CRQ0211" QSTEST = "CRQ02-Energy"
QSORRES | QSSTRESC | QSSTRESN |
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No energy at all | 1 | 1 |
A little energy | 2 | 2 |
Some energy | 3 | 3 |
Moderately energetic | 4 | 4 |
Quite a bit of energy | 5 | 5 |
Very energetic | 6 | 6 |
Full of energy | 7 | 7 |
QSTESTCD = "CRQ0218" QSTEST = "CRQ02-Happy, Satisfied or Pleased"
QSORRES | QSSTRESC | QSSTRESN |
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Very dissatisfied, unhappy most of the time | 1 | 1 |
Generally dissatisfied, unhappy | 2 | 2 |
Somewhat dissatisfied, unhappy | 3 | 3 |
Generally satisfied, pleased | 4 | 4 |
Happy most of the time | 5 | 5 |
Very happy most of the time | 6 | 6 |
Extremely happy, could not be more satisfied or pleased | 7 | 7 |
End of Document