- 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.
- Refer to Glossary and Abbreviations to gain familiarity with common terms and abbreviations used in this document.
- Read the CDISC models upon which the TIG is based, described in Relationship to CDISC Standards and Resources, to gain familiarity with the models and the basic rules for how they are implemented.
- Read Section 2, Standards for Tobacco Product Studies, to guide implementation of standards for collection, representation, and exchange of tobacco product study data.
- Refer to additional CDISC standards and resources described in Relationship to CDISC Standards and Resources, when needed.
- Read Section 3, Examples, to support understanding of implementation guidance.
- Refer to Appendices as necessary.
- Revisit any sections of particular interest.
- 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., to allow implementers to reference rows in tables without describing row contents). Values in Num have no meaning beyond this use.
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