The Trial Visits (TV) domain contains the planned order and number of visits in the study within each arm. The Trial Design datasets—Trial Arms (TA) and Trial Elements (TE)—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 studies which illustrate TV and the development of the TA and TE datasets. TOBA-696 - Getting issue details... STATUS
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