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Tobacco Products Product Identifiers and Descriptors (TO) is a study reference dataset (see Tobacco Product Identifiers and Descriptors (TO) Specification) that provides a mechanism for uniquely identifying a tobacco product. It is similar to Device Identifiers (DI) in function. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID) (similar to Sponsor Device Identifier (SPDEVID) a consistent variable, that is available for use in other domains where data pertaining to the product may be found.
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the origin of the applicant-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. 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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