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Make sure to include in Fundamentals section with related guidance:   

  • The lower-case letters "w", "xx", "y", and "zz" that appear in a variable name or label in this document must be replaced in the actual variable name or label using the following conventions:
    • The lower-case letter "y" in a variable name (e.g., SITEGRy) refers to a grouping or other 
      categorization scheme, an analysis criterion, or an analysis range, and is replaced with an integer 
      [1–99, not zero-padded]. Truncation of the original variable name may be necessary in rare 
      situations when a 2-digit index is needed and causes the length of the variable name to exceed 8 
      characters. In these situations, it is recommended that the same truncation be used for both the 
      character and numeric versions of the variables in a variable pair.


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

Stratum y

Req

Indicates stratification factors used when calculating the value of the input parameter. 

"y"  that defines the topic of the observation.

STRMVALy

Stratum y Value

Req

Identifies the stratum with which the input parameter is associated.


INPRM

Input Parameter

Perm

Indicate the calculated input parameter for the stratum or strata.

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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