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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 PARVARy | Stratum y Parameter Variable y | Req | Variable y that defines the topic of the observation | ||||||
STRMVALy PARVALy | Stratum y Value Parameter Variable Value y | Req | Value of PARVARy associated with the observation | ||||||
| REFVARy INPRM | Reference Variable y | Req | Variable y that defines the topic of the column | REFTYP | REFTYP | Input Parameter | Reference Type | Perm | This is the input parameter for which the value is calculated Type of reference data captured in the observation |
INPRMVAL REFVAL | Input Parameter Value Reference Value | Req | This is the value of the input parameter Reference value defined by the parameter and column variable values | ||||||
INPARMU REFVALU | Input Parameter Unit Reference Value Unit | Cond | Unit associated with the input parameter value Unit associated with the reference value | ||||||
| REFORD | Reference Order | Req | Grouping value to tie together descriptors of of a reference cell value |
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