The identifier variables associated with the reference values are captured in the STRTMy (Stratum y) variables. The actual values of the STRTMy variables are captured in the STRVALy (Stratum y Value) variables As many identifiers as necessary based on the source data should be captured in the reference dataset and the order of the stratum variables has no inherent meaning so ordering is not defined in this section. The convention of y is used as an index value indicating an integer with a value of 1-99 (as described in the ADaM standard section). There is no requirement that the stratum variables start with 1, nor must the variables use consecutive values. Some examples of stratum variables are Year, Sex, Race, Age, Transition type, and product.
The source fiel may change over time so capturing the name of the source file either in the dataset or the deifne file allows for traceability back to the source. I f the source name is captured in the dataset then REFSRCE (Reference Data Source) is the variable to use.
| Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
STRTMy | Stratum y | Char | | Req | Indicates stratification factors used when calculating the value of the input parameter. |
STRVALy | Stratum y Value | Char | | Req | Identifies the stratum with which the input parameter is associated. |
INPRM | Input Parameter | Char | | Perm | Indicate the calculated input parameter for the stratum or strata. |
INPRMVAL | Input Parameter Value | Num | | Req | This is the value of the input parameter. |
INPRMU | Input Parameter Unit | Char | | Perm | Unit associated with the input parameter value. |
REFSRCE | Reference Data Source | Char | Perm | Information identifying the source of the reference data - this may be captured in the dataset or in the define file |
Overview
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