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This section describes how to use implement CDISC standards for the collection, representation, and representation exchange of tobacco product study data. Standards in this guide support use data with focus on implementation for use cases inherent to studies of tobacco productsproduct data. Use cases selected are comprised of in this guide comprise concepts identified by one 1 or more stakeholders as important in the context of tobacco product studies and fall in the following general categoriesresearch.
The following use cases are specifically addressed in the TIG:
- Product Descriptiondescription, for data which characterize a product.
- Trial Design, for data which describe the design of a study
- 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 Nonclinical, for data from in vitro and in vivo nonclinical studies
- Product Impact impact on Individual Health, for data individual health, which refers to concepts used to assess the impact on of a product tobacco products on individuals individuals
- Product Impact impact on Population Health, for data population health, which refers to concepts used to assess the impact of a product on a population of individuals
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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