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Requirements for data submission are defined and managed by the regulatory authorities to whom data are submitted. This section describes general requirements for datasets which may be part of a submission. However, additional conventions may be defined by regulatory bodies or negotiated with regulatory reviewers. In such cases, additional requirements must be followed.

Tabulation Datasets

langauge from here https://www.cdisc.org/kb/articles/domain-vs-dataset-whats-difference

Observations about study subjects are represented in a series of domain datasets. Generally, a domain is represented by a single 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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