The Trial Design datasets—Trial Arms (TA) and Trial Elements (TE)—based on the Trial Design Model describe the planned design of the study, and provide the representation of the study product in its most granular components, as well as the representation of all sequences of these components as described in the protocol. The TA and TE datasets are interrelated, and they provide the building blocks for the development of actual subject-level information included in the Demographics (DM) and Subject Elements (SE) domains.
This section includes example trials, which illustrate the development of the TA and TE datasets.
Overview
Content Tools