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 |
|---|---|---|---|
| PARVARy | Parameter Variable y | Req | Variable y that defines the topic of the observation |
| PARVALy | Parameter Variable Value y | Req | Value of PARVARy associated with the observation |
| REFVARy | Reference Variable y | Req | Variable y that defines the topic of the column |
| REFTYP | Reference Type | Perm | Type of reference data captured in the observation |
| REFVAL | Reference Value | Req | Reference value defined by the parameter and column variable values |
| REFVALU | Reference Value Unit | Cond | Unit associated with the reference value |
Overview
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