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Observations generated over the course of a study are represented in a series of datasets aligned with logical groupings of data per domains. Domains described in this guide are generally aligned with implementation of a single dataset in which to represent data in scope for a domain.All datasets are structured as flat files with rows representing observations and columns representing variables.In some cases, a dataset implemented for a domain may be split into physically separate datasets to support submission when needed and as allowable by the regulatory authority. 

The following conventions guidance will be followed when implementing tabulation datasets: 

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