- TO is a study reference dataset that provides a consistent identifier, the Sponsor-defined Tobacco Product Identifier (SPTOBID), for a tobacco product in a study. It contains the identifying and descriptive characteristics of a tobacco product and merges those characteristics on this single identifier.
- SPTOBID is sponsor-defined, but it must be unique with regard to the identifying and descriptive characteristics contained in the TO dataset.
- SPTOBID can be used in any dataset TOBA-77 - Getting issue details... STATUS SDTM-716 - Getting issue details... STATUS where there are records pertaining to the tobacco product it identifies/describes.
- SPTOBID should be used through all phases of the development lifecycle for the product it identifies/describes.
- TOCAT is a required variable used to differentiate records relating to a new product from those relating to a predicate product, subject to the published controlled terminology for this variable.
- TOSCAT (Sub-category) can be used to group records by identifying characteristic (e.g., manufacturer, trade name, etc) and descriptive characteristics (length, circumference, etc).
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