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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.


VariableLabelCoreNotes

STRTMy

PARVARy

Stratum y

Parameter Variable y

ReqVariable y that defines the topic of the observation

STRMVALy

PARVALy

Stratum y Value

Parameter Variable Value y

ReqValue 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

INPRMU

REFVALU

Input Parameter Unit

Reference Value Unit

Perm

Unit associated with the input parameter value

Unit associated with the reference value

REFORDReference OrderReqGrouping value to tie together descriptors of of a reference cell 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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