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Guidance in this This section describes how to use implement CDISC standards for the collection, representation, and representation exchange of tobacco product study data.The TIG provides guidance for how to implement CDISC models to standardize collection and representation of tobacco product study data.Standards in this guide are applicable to use cases 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 are organized in the following categoriesresearch.
The following use cases are specifically addressed in the TIG:
- Product Descriptiondescription, for use cases which characterize a product
- Trial Design, for standards which describe the design of a study
- 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 Nonclinical, for both in vitro and in vivo nonclinical study use casesstudies
- Product Impact impact on Individual Health, for use cases 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 use cases population health, which refers to concepts used to assess the impact of a product on a population tobacco products on populations of individuals
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