Page History

This document guide is organized into the following sections:

• Section 1, Introduction, provides an overall introduction to the TIG v1.0.
• Section 2, Fundamentals of the Standard, recaps 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.
• guide describing its purpose, organization, and relationship to other CDISC standards and resources.
• Section 2, 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.