An analysis dataset that follows ADaM BDS (i.e., an analysis dataset of the BDS class) can contain multiple analysis parameters. In a BDS analysis dataset, the variable PARAM contains a unique description for every analysis parameter included in that dataset. The variable PARAMCD contains the short name of the analysis parameter in PARAM, with a one-to-one mapping between the 2 variables. Each value of PARAM identifies a set of 1 or more rows in the dataset.

The metadata for the columns (variables) in the dataset often depend on the values of PARAM/PARAMCD. This concept is analogous to that of value-level metadata for a single variable in SDTM, but in the BDS it is quite common that the metadata of several variables vary by PARAM/PARAMCD. To describe how variable metadata vary by PARAM/PARAMCD, the metadata element PARAMETER IDENTIFIER is required in variable-level metadata for a BDS analysis dataset. This PARAMETER IDENTIFIER metadata element identifies which variables have metadata that vary depending on PARAM/PARAMCD, and links the metadata for a variable to the appropriate value of PARAM/PARAMCD.

Controlled terminology reduces the need to enter the same metadata for a variable for multiple values of PARAM/PARAMCD:

  • The use of “*ALL*” in the PARAMETER IDENTIFIER for a variable indicates that the metadata for that variable is the same for all values of PARAM/PARAMCD in the analysis dataset.
  • The use of “*DEFAULT*” in the PARAMETER IDENTIFIER for a variable indicates that the specified metadata for that variable should be considered the metadata for all values of PARAM/PARAMCD in the analysis dataset unless otherwise specified.

A particular value of PARAMCD in the PARAMETER IDENTIFIER for a variable indicates that the specified metadata for that variable should be considered the metadata applicable to the particular PARAMCD, overriding the specified *DEFAULT* metadata, if any.

How to capture analysis metadata is described in the Define-XML specification.


Num

Analysis Variable Metadata Field

Description

1

PARAMETER IDENTIFIER

Contains either:

  • the value of PARAMCD that identifies the analysis parameter to which the variable metadata applies; or
  • controlled terminology to indicate groupings of analysis parameters:

*ALL* - Used when the variable metadata applies to all analysis parameters in the dataset.

*DEFAULT* - Used when the variable metadata applies to all analysis parameters in the dataset except for those specifically listed within the metadata.


By referencing the codelist for PARAMCD, the user of the dataset can determine the unique analysis parameter values found in the dataset and is able to determine the analysis parameter-specific attributes and derivation algorithms for each variable when PARAMCD is a specific value.

Note that for the PARAMCD variable, the parameter identifier is “PARAMCD.” The list of values that exist for the variable also serves as an index of the analysis parameters and parameter identifiers included in the analysis dataset.

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