| 2021-08-27 | 2.0 Revision Draft | - Converted the supplement to the current WIKI QRS supplement template.
- Updated the title by adding the QSCAT value at the end (e.g., (EXACT) and match the full titile
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-324 |
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stated in the User Manual. - Annotated CRF updated to the MSG V2.0 annotation guidelines
- Added assumption 2 on using the QSEVINTX variable and added it to the example.
- Added assumption 3 on the inclusion of 4 respiratory symptom raw and domain scores, a raw EXACT total and an EXACT total scores as described in the user manual.
- Added assumption 4 to describe how QRS planned diary data aligns with the QS domain timing variables.
- Added assumption 5 regarding the need for a record of each day of the study. The example was updated with a diary day having no responses.
- The QSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
- Updated the example to represent all 7 diary days related to VISITNUM = 1 to indicate the dairy days are planned observations with the QSDTC dates represented.
- Revised the QSSTRESC and QSSTRESN values in the example and section 4 to values of "xxx" to represent numeric values based on the user manual describes on how these numeric values are represented.
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