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Tobacco Products Product Identifiers and Descriptors (TO) is a study reference dataset (see Tobacco Product Identifiers and Descriptors (TO)) that provides a mechanism for uniquely identifying a tobacco product. It is the origin of the sponsorapplicant-defined tobacco product identifier (SPTOBID). This identifier is additionally used in any dataset containing records that pertain to the product at all stages of the product development lifecycle, including nonclinical testing and testing in human subjects.
The example below illustrates TO concepts using a cigarette product for demonstration purposes. The Product Design Parameters and Conformance Testing section additionally demonstrates this dataset for an ENDS product and a portioned snus product.
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. See Section 2.8.8.1., SDTM Tobacco Product Identifiers and Descriptors (TO), for a detailed description and specification table for this dataset.
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The example in this section demonstrates how to identify both a new product and a predicate product. Subsequent examples in this guide focus only on new products, in order to keep the tables concise and easier to review. In reality, many of the examples in this guide would contain data on both the new and predicate product, and the SPTOBID for both products would be used with every dataset on any record that pertains to the associated product. Each unique new product and each unique predicate, original, or comparison product would be assigned a unique SPTOBID value which would be associated with a block of records for their identifying and descriptive characteristics in the TO dataset. |
Include Page SDTM Example. Tobacco Product Identifiers and Descriptors - New and Predicate Product SDTM Example. Tobacco Product Identifiers and Descriptors - New and Predicate Product
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Overview
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