This section describes how to use CDISC standards for the collection and representation of tobacco product study data. Standards address 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 can be grouped in the following general 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
Guidance 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 guide the use of controlled terminology and formats across standards.
- Standards for Collection, to guide the use of standards for data collection.
- Standards for Tabulation to guide the use of standards for data tabulation.
- Standards for Analysis to guide use of standards for data analysis.
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