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1. This guide It is recommended users of this guide review and understand applicable regulatory submission requirements prior to reading this guide. The TIG v1.0 does not address or define regulatory submission requirements. Requirements for data submission are defined and managed by regulatory authorities to whom data are submitted. It is therefore recommended users of this guide review and understand applicable requirements prior to reading this guide.
2. Read the foundational standards upon which this document is based, referenced in Relationship to CDISC Documents, to gain familiarity with data models and the basic rules for how they are implemented. These standards are available at: http://www.cdisc.org/.Read this guide all the way through (without skipping any sections) at least once.
3. Read Section 2 2, Fundamentals of the Standard, and/or take CDISC's free training module <add link here> for an understanding of what to specifically expect from this guide. 
4. Finally, revisit any sections of particular interest.

The SDTMIG is best read online, so the reader can benefit from the many hyperlinks to internal and external references. The following guidelines may be helpful in reading this document:

1. Read the following sections to guide implementation of standards for key areas of tobacco research:
   1. Section 
2. Refer to appendices
3. First, read the SDTM to gain a general understanding of SDTM concepts.
4. Next, read Sections 1-3 of this document to review the key concepts for preparing domains and submitting data to regulatory authorities. Refer to Appendix B, Glossary and Abbreviations, as necessary.
5. Read Section 4, Assumptions for Domain Models (Copy). 
6. Review Section 5, Models for Special-purpose Domains (Copy), and Section 6, Domain Models Based on the General Observation Classes (Copy), in detail, referring back to Section 4, Assumptions for Domain Models (Copy), as directed. See the implementation examples for each domain to gain an understanding of how to apply the domain models for specific types of data.
7. Read Section 7, Trial Design Model Datasets (Copy), to understand the fundamentals of the Trial Design Model and consider how to apply the concepts for typical protocols.
8. Review Section 8, Representing Relationships and Data (Copy), to learn advanced concepts of how to express relationships between datasets, records, and additional variables not specifically defined in the models.
9. Review Section 9, Study References (Copy), to learn about occasions when it is necessary to establish study-specific references that will be used in accordance with subject data.
10. Finally, review the appendices as appropriate. Appendix C, Controlled Terminology, in particular, describes how CDISC Terminology is centrally managed by the CDISC Controlled Terminology Team. Efforts are made at publication time to ensure all SDTMIG domain/dataset specification tables and/or examples reflect the latest CDISC Terminology; users, however, should refer to https://www.cancer.gov/research/resources/terminology/cdisc as the authoritative source of controlled terminology, as CDISC Controlled Terminology is updated on a quarterly basis.

This implementation guide covers most data collected in human clinical trials, but separate implementation guides provide information about certain data, and should be consulted when needed. The following guides are available at https://www.cdisc.org/standards/foundational/sdtmig:

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1. necess.
2. Revisit any sections of particular interest. 
3. Read this guide all the way through (without skipping any sections) at least once.