Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

The ADaM BDS structure contains a central set of columns (i.e., variables) that represent the data being analyzed. These variables include the value being analyzed (e.g., AVAL) and the description of the value being analyzed (e.g., PARAM). Other columns in the dataset provide more information about the value being analyzed (e.g., the subject identification) or describe and trace its derivation (e.g., DTYPE) or support its analysis (e.g., treatment product variables, covariates). Standard columns exist for a variety of purposes, such as SDTM record identifiers for traceability, population and other record selection flags, analysis values, and some standard functions of analysis values. Permissible columns are not limited to those whose variable names are specified in Predefined Standard Variables for ADSL, Predefined Standard Variables for BDS, Predefined Standard Variables for OCCDS, and may include study-specific analysis model covariates, subgrouping variables, variables supportive of traceability, and other variables needed for analysis or useful for review.

...