You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 11 Next »

Description

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.

to.xpt, Tobacco Product Identifiers and Descriptors — Study Reference. One record per parameter code per applicant-defined tobacco product, Tabulation.


Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
Identifier

Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected.

Req
DOMAINDomain AbbreviationCharTOIdentifierTwo-character abbreviation for the domain.Req
SPTOBID

Applicant-Defined Tobacco Product ID

Char


IdentifierIdentifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. It must be unique for each unique tobacco product as defined by the specific values of the product's TOPARMCD-TOVAL pairs.Req
TOSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) within the dataset.Req
TOPARMCDTobacco Product ID Element Short NameChar

(TOPARMCD)

TopicShort name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF".Req
TOPARMTobacco Product ID Element NameChar

(TOPARM)

Synonym QualifierName of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference".Req
TOCATCategory of Tobacco Product ID ElementChar(TOCAT)Grouping QualifierUsed to define a category of records based on whether the product is new or a predicate product Examples: "NEW PRODUCT", "PREDICATE PRODUCT", "ORIGINAL PRODUCT", and "COMPARISON PRODUCT".Req
TOSCAT

Subcategory of Tobacco Prod ID Element

Char
Grouping QualifierUsed to define a sub-category of related records (e.g., PRODUCT IDENTIFIER, PRODUCT DESCRIPTOR).Perm
TOVAL

Tobacco Product ID Element Value

Char
Result QualifierValue for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID.Req
TOVALUTobacco Product ID Element Value UnitChar

(UNIT)

Result QualifierUnit for the value in TOVAL. Will be blank for unitless identifying descriptors (e.g., "Trade Name"). Must be used where applicable (e.g., "Circumference").Perm


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.

  • No labels