Guidance in this section describes how to use CDISC standards for the collection and representation of tobacco product study data. Standards in this section are aligned with use cases inherent to studies of tobacco products. Use cases selected are comprised of concepts identified by one or more stakeholders as important in the context of tobacco product studies and are organized in the following categories:
- Product Description, for use cases which characterize a product.
- Trial Design, for standards which describe the design of a study
- Nonclinical, for both in vitro and in vivo nonclinical study use cases
- Product Impact on Individual Health, for use cases to assess the impact on of a product on individuals
- Product Impact on Population Health, for use cases to assess the impact of a product on a population of individuals
How To Determine Where Data Belong - Tobacco Implementation Guide (TIG) v1.0 - Wiki (cdisc.org)
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