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1. It is recommended users of this guide review and understand applicable regulatory submission requirements prior to reading this guide. The TIG does not address or define regulatory submission requirements. Requirements for data submission are defined and managed by the regulatory authorities to whom data are submitted.

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. First, read the SDTM to gain a general understanding of SDTM concepts.
2. 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 necessaryto gain familiarity with common terms and abbreviations used in this document.
3. Read Section 4, Assumptions for Domain Models (Copy). 
4. 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.
5. 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.
6. 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.
7. 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.
8. Finally, review the appendices as appropriate. Appendix C, Controlled Terminology (Copy), 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. the CDISC models upon which the TIG is based, described in Section 1.3, Relationship to CDISC Standards and Resources, to gain familiarity with the models and the basic rules for how they are implemented.
2. Read Section 2, Standards for Tobacco Product Data, to guide implementation of standards for collection, representation, and exchange of tobacco product data.
3. Refer to additional CDISC standards and resources described in Section 1.3, Relationship to CDISC Standards and Resources, when needed.
4. Read Section 3, Examples, to support understanding of implementation guidance.
5. Refer to Appendices as necessary.
6. Revisit any sections of particular interest.
7. Read this guide all the way through (without skipping any sections) at least once.

Tables in this guide may begin with column Num. Values in Num are consecutive numbers intended only to support ease of use (e.g., allowing implementers to reference rows in tables without describing row contents). Values in Num have no meaning beyond this use

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