- 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.
- Read the CDISC models TOBA-8 - Getting issue details... STATUS 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 Section 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.
- Read Section 3, Trial Design to guide implementation of standards to represent design of trials included in a submission.
- Read the following sections to guide implementation of standards for key areas of tobacco research:
- Section 4, Product Description
- Section 5, Nonclinical
- Section 6, Clinical - Product Impact on Individual Health
- Section 7, Clinical – Product Impact on Population Health
- Refer to appendices as necessary, including Appendix B, Glossary and Abbreviations.
- Revisit any sections of particular interest.
- Read this guide all the way through (without skipping any sections) at least once.
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