The COMFORT-B SCALE example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the COMFORT-B SCALE instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented in QSORRES. When there are numeric results, the result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC. When the results are character only, the result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument.
The table represents the items from the COMFORT-B SCALE instrument. | Rows 1-12: | Represent the questions from the Comfort-B Scale for subject 2324-P0001 at visit 1. Row 4 represents the conditional branching item for the item "Crying". Only the first evaluation is represented (RSREPNUM=1). | | Rows 13-24: | Represent the missing data from the Comfort-B Scale for subject 2324-P0001 at visit 2. Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing
the visit was not collected, and no date is assumed for when the visit would have occurred. The following variable RSMETHOD is also not represented when this happens. Only the first evaluation is represented (RSREPNUM=1). |
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