Organization of this Document

This document 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 in concert 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, Domain Models Based on the General Observation Classes (Copy), provides specific metadata models based on the 3 general observation classes, along with assumptions and example data.
• Section 7, Trial Design Model Datasets (Copy), describes domains for trial-level data, with assumptions and examples.
• Section 8, Representing Relationships and Data (Copy), describes how to represent relationships between separate domains, datasets, and/or records, and provides information to help sponsors determine where data belong in the SDTM.
• Section 9, Study References (Copy), provides structures for representing study-specific terminology used in subject data.
• Appendices provide additional background material and describe other supplemental material relevant to implementation.