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  1. 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.
    1. SPTOBID is sponsor-defined, but it must be unique with regard to the identifying and descriptive characteristics contained in the TO dataset.
    2. SPTOBID can be used in any dataset
      Jira
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      serverIssue Tracker (JIRA)
      serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
      keyTOBA-77
      Jira
      showSummaryfalse
      serverIssue Tracker (JIRA)
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      keySDTM-716
      where there are records pertaining to the tobacco product it identifies/describes.
    3. SPTOBID should be used through all phases of the development lifecycle for the product it identifies/describes.
  2. 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.
  3. TOSCAT (Sub-category) can be used to group records by identifying characteristic (e.g., manufacturer, trade name, etc)  and descriptive characteristics (length, circumference, etc).