Approaches to creating ADaM subject-level analysis datasets (ADSL) for integrated analyses

Abstract

AbstractWhen it comes to integration the SDTM Model and IG do not give very much guidance. There is much discussion about the need for Integrated Summary of Safety (ISS)/Integrated Summary of Efficacy (ISE) level SDTM datasets and how to create those versus not needing integrated SDTM. The SDS and ADaM team have a subteam that are working to address this topic, but the work is still in early development. From an ADaM perspective, there is generally a requirement for integrated analysis datasets. There are many ADaM variables that have to be modified or added to allow for integrated analyses. Whether these datasets can or should be created on a project level and just stacked together for ISS/ISE analysis or if there is a need for the creation of integrated datasets depends on the nature of the variable updates and requirements. ADSL can present a unique set of challenges. Whether there should be one record per subject or one record per subject per study, treatment start and stop dates and groupings for ana...