Description

A special-purpose domain that lists the target, minimum, and maximum allowable values for design parameters of a product as allowed per manufacturer specifications. Therefore these data are not experimentally determined.

pd.xpt, Product Design Parameters — Special-Purpose. One record per parameter code per unit of measure per applicant-defined tobacco product, Tabulation.


Specification

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

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Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique 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 AbbreviationCharPDIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDApplicant-Defined Tobacco Product IDChar
IdentifierIdentifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier.Req
IGDCMPIDIngredient or Component IdentifierChar
IdentifierIdentifier given to an ingredient, substance or component of a tobacco product .(e.g., "Burley Tobacco", "Reconstituted Tobacco"). It originates in the IT or IN domain. See PD assumption 2 below for more info.Perm
PDSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a design parameter within a tobacco product (SPTOBID) within the dataset.Req
PDPARMCDDesign Parameter Element Short NameChar(PDPARMCD)TopicShort name of the parameter being described. Examples: "TOCUTSIZ", "BATCAPC".Req
PDPARMDesign Parameter Element NameChar

(PDPARM)

Synonym QualifierName of the parameter being described. Examples: "Tobacco Cut Size", "Battery Capacity".Req
PDVALTRGDesign Parameter Element Target ValueChar
Result QualifierTarget value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.Req
PDVALMIN

Design Parameter Element Minimum Value

Char
Result QualifierMinimum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.Exp
PDVALMAX

Design Parameter Element Maximum Value

Char
Result QualifierMaximum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.Exp
PDVALUDesign Parameter Element Value UnitChar(UNIT)Result QualifierThe single unit for the values in PDVALTRG, PDVALMIN and PDVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). Must be used where applicable (e.g., "Circumference").Perm


Assumptions

  1. PD is a special-purpose domain for listing the design parameters of a product as specified by the manufacturer. These parameters are listed with their target, minimum, and maximum values allowed by the design. They are not test data (i.e., these are not experimentally determined values). Testing for manufactured product conformance to these listed specifications is represented in the Tobacco Product Testing (PT) domain.
  2. IGDCMPID is a permissible variable in PD whose value originates in the Tobacco Ingredients (IT) or Non-Tobacco Ingredients (IN) domain. When a design parameter value varies by ingredient or component, IDGCMPID is used to indicate the ingredient or component to which the parameter value applies.
  3. PDUNIT represents the single, unified unit for all 3 values shown in PDVALTRG, PDVALMIN, and PDVALMAX (i.e., target, minimum, and maximum values, respectively).
  4. Design parameter data must be provided for all new tobacco products in the application.

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