At least 1 product variable is required in a BDS dataset. This requirement is satisfied by any of the subject-level product variables (e.g., TRTxxP) or record- level product variables (e.g., TRTP). All product variables defined in Table 3.3.2.1 are record level, meaning that the values contained in the variable may vary by record within a subject. Subject-level product variables are described in ADSL Product Variables #2.
All dose variables defined in the table below are record level. This means that the values contained in the variable may vary by record within a subject. These record-level dose variables, plus ADSL subject-level dose variables, can be used in addition to, but not instead of, record-level product variables.