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Tabulation Datasets

Observations generated over the course of a study about tobacco products and study subjects generated for a submission 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. 

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Metadataspec
NumGuidanceImplementation
1Dataset Content

Data represented in tabulation datasets will include the following per regulatory requirements and standards in this guide:

  • Data as originally collected or received.
  • Data from the protocolrelevant external references (such as a protocol).
  • Assigned data.
  • Derived data.
2Dataset NamingEach domain dataset is distinguished by a unique, 2-character code that should be used consistently throughout the submission. This code, which is stored in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data).
3Splitting Datasets

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