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This section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product study data. Implementation of standards described in this section addresses use cases for data inherent to studies of tobacco products. Use cases selected are comprised of concepts identified by one data with focus on implementation for use cases inherent to tobacco product data. Use cases in this guide comprise concepts identified by 1 or more stakeholders as important in the context of tobacco product studies and for the following categories:
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research.
The following use cases are specifically addressed in the TIG:
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Data to characterize a product.
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- Product description, which refers to concepts used to characterize tobacco products
- Nonclinical, which refers to concepts used to identify potential risks and effects on biological processes for tobacco products via
- in vitro and in vivo nonclinical studies
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- Product
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- impact on individual health, which refers to concepts used to assess the impact
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- of
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- tobacco products on individuals
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- Product
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- impact on population health, which refers to concepts used to assess the impact of
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Guidance in this section is organized in the following sections:
- How To Determine Where Data Belong, to guide the selection of standards to use based on the data to be collected and represented.
- How to Use Controlled Terminology, to describe expectations for use of controlled terminology and formats across standards.
Finalize when all sections are drafted.
- Standards for Collection, to guide the implementation of standards for data collection.
- Standards for Tabulation to guide the Implementation of standards for data tabulation.
- Standards for Analysis to guide the implementation of standards for data analysis.tobacco products on populations of individuals
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