This contains the Trial Design datasets that describe the planned design of the study, and provide the representation of study product in its most granular components, as well as the representation of all sequences of these components as descripted 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) domain.
This section includes example trials, which illustrate the development of the TA and TE dataset.
Overview
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