- 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.
- Read the CDISC models upon which this document is based, referenced in Relationship to CDISC Documents, to gain familiarity with the models and the basic rules for how they are implemented. These standards are available at: http://www.cdisc.org/.
- Read Section 2, Standards for Tobacco Product Studies, to guide implementation of standards for collection and representation of tobacco product study data.
- 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.
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