Page History

This document guide is organized into the following sections:

• Section 1, Introduction, provides an overall introduction to the TIG v1.0guide describing its purpose, organization, and relationship to other CDISC standards and resources.
• Section 2, Collection and Representation of Study Data, provides the basic concepts of models which support the TIG v1.0 and describes how this implementation guide should be used with these models.
• Section 3, Trial Design, describes implementation of standards to represent the design of trials included in a submission.
• Section 4, Product Description, describes implementation of standards to represent data which characterizes a tobacco product.
• Section 5, Nonclinical, describes implementation of standards to represent data from nonclinical studies of tobacco products.
• Section 6, Clinical - Product Impact on Individual Health, describes implementation of standards to represent data from clinical studies to assess impact of tobacco products on individual health.
• Standards for Tobacco Product Data, describes how to use CDISC standards and resources for the collection, representation, and exchange of tobacco product data.
• Section 3, Examples, provides examples to demonstrate the intended use of CDISC standards for tobacco product dataSection 7, Clinical – Product Impact on Population Health, describes implementation of standards to represent data used in clinical models to assess impact of tobacco products on population health.
• Appendices provide additional background material and describe other supplemental material relevant to implementationto support implementation.