Types of ADaM Data Sets

The ADaM data set can be one of these types:

An ADAE data set relies on one or more of the treatment variables (for example, TRTP, TRTA, TRTxxP, and TRTxxA) in an ADSL data set. Therefore, you must create an ADSL data set before an ADAE data set. When you create an ADAE data set, you must include the ADSL data set as a source data set.

Only one ADSL data set can be associated with a study or submission.

The BDS data set contains two variables that are required and are key fields: USUBJID and PARAMCD. They are automatically selected to be included in the data set.

The variable AVISIT is also a key field, but it is conditional. You must explicitly select it if your BDS data set includes visit-specific data.