Proposed standard structure designed to capture reference data that is not captured in SDTM and may be used as input into SDTM or ADaM creation.
| Variable | Label | Core | Notes |
|---|---|---|---|
STRTMy | Stratum y | Req | Variable y that defines the topic of the observation |
STRMVALy | Stratum y Value | Req | Value of PARVARy associated with the observation |
INPRM | Input Parameter | Perm | This is the input parameter for which the value is calculated |
INPRMVAL | Input Parameter Value | Req | This is the value of the input parameter |
INPRMU | Input Parameter Unit | Perm | Unit associated with the input parameter value |
Reference data is typically provided in spreadsheet format where each cell of reference data is defined by row identifiers and column identifiers. When capturing the data in standardized format the decision has been made that recreating the original reference data in the original format is not a desired function and therefore whether the identifier is from a row versus a column is not of importance. These identifiers are captured as STRATUM (STRTMy). In addition a description of the content of the cell is captured as a topic (INPRM), the actual value in the cell (INPRMVAL) and a description of the unit if relevant (INPRMU) are defined in the dataset metadata.
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