SDTM Tobacco Product Identifiers and Descriptors (TO)

A study reference dataset that provides a consistent identifier (SPTOBID) for the representation of a tobacco product. The dataset contains a list of the identifying and descriptive characteristics of the tobacco product.

Assumptions

1. 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. This dataset is required for studies of tobacco products.
   1. SPTOBID is applicant-defined, but it must be unique with regard to the identifying and descriptive characteristics contained in the TO dataset.
   2. SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT), Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (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). Every value of SPTOBID in any dataset must correspond to a product described in the TO dataset.
   3. SPTOBID should be used through all phases of the development lifecycle for the product it identifies/describes.
2. TOPARMCD is the topic variable for this dataset. A minimally meaningful TO dataset must include at least the parameter for tobacco product category (TOPARMCD = TPRDCAT)
3. 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.
4. TOSCAT (Sub-category) can be used to group records by identifying characteristic (e.g., manufacturer, trade name, etc)  and descriptive characteristics (e.g., length, circumference).
5. A minimally conformant TO dataset must include the parameters for Tobacco Product Category, Manufacturer, and Trade Name.