Predefined Standard Variables for BDS

A BDS dataset contains 1 or more records per subject, per analysis parameter, per analysis timepoint. An analysis timepoint is conditionally required, depending on the analysis. In situations where there is no analysis timepoint, the structure is 1 or more records per subject per analysis parameter. Typically there are several BDS datasets in a study. This section of the TIG defines the standard variables used in BDS datasets. See Section 2.9.5, Predefined Standard Variables for ADSL, for ADSL variables, any of which may also be included in BDS datasets to support traceability or enable analysis.

In this section, "within a given study, subject, and dataset" is implied, unless otherwise stated. For example, the description of ABLFL defines it as a variable that indicates baseline record for each parameter, or, if there is more than 1 baseline definition, for each parameter and baseline type (BASETYPE). It should be understood that the baseline record is for the subject identified by USUBJID. In addition, note that "within a parameter" means "within a parameter within a dataset."