The SDTM Implementation Guide for Associated Persons (SDTMIG-AP) v1.0 provides guidance on how to include data collected about persons who are not the study subjects in SDTM. However, the ADaM Implementation Guide has not provided guidance regarding how to include data from SDTM AP-- domains in ADaM datasets if needed for analysis.
The ADaMIG provides multiple ways to categorize and flag values to be analyzed. These ways may seem overlapping, and the most appropriate set of variables for a particular analysis may not be obvious to the user. This article is intended to provide some clarity on how to use appropriate variables and how to select the appropriate analysis variables.
When development of the SDTM and SDTMIG started, SAS was used almost universally across the pharmaceutical industry and at the US FDA.