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 |
INPRM 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 |
Overview
Content Tools