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3.2 Example for the C-SSRS BASELINE QS Domain Model
The C-SSRS BASELINE example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit and another subject at baseline and visit 2 for the C-SSRS BASELINE instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC. When a result is character only, the result is transformed into the standard character representation in QSSTRESC and QSSTRESN is null.
The table represents the items from the C-SSRS BASELINE instrument.
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Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead. For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:
When the reason is collected for a not done visit, information or a row description should be added as follows:
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The suppqs dataset shows the items in the qs dataset which have assigned responses (QSDRVFL = "Y") due to conditional branching.
The table represents the items from the QRS Short_Name instrument.
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