- TO is a study reference dataset that provides a consistent identifier, the Applicant-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 applicant-defined, but it must be unique with regard to the identifying and descriptive characteristics contained in the TO dataset.
- SPTOBID is used in the PD, IT, IN and IQ domains, as well as any domain in the general observation classes where there are records pertaining to the tobacco product it identifies/describes (e.g., PT). TOBA-77 - Getting issue details... STATUS SDTM-716 - Getting issue details... STATUS
- 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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