SDTM Example. ENDS Design Parameters

The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example makes use of TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the two distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

The manufacturing parameter specifications of the ENDS product as intended for used are represented in the Product Design Parameters (PD) domain. The example below shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 

Finally, the Tobacco Product Testing (PT) domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one replicate per parameter is shown. Note that PTREPNUM (repetition number) =1 for all rows.