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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. when data have been collected. Domains Domains described in this guide are generally aligned with implementation of a single dataset for each domain. 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 in alignment with 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 will be followed when implementing tabulation datasets: 

Generally, a domain is represented by a single dataset. 

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To ensure split datasets can be appended back into one domain dataset:

All datasets are structured as flat files with rows representing observations and columns representing variables. Data represented in tabulation datasets will include:

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Dataset names will reflect the following conventions:

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