The Tobacco Implementation Guide (TIG) Version 1.0
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has been prepared by | Jira |
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the Tobacco Implementation Guide team | Jira |
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(TIG v1.0) has been prepared by the Tobacco Implementation Guide Team of the Clinical Data Interchange Standards Consortium (CDISC)
with support from the U.S. Food & and Drug Administration (FDA) Center for Tobacco Products (FDA CTP) using the CDISC standards development process. The TIG v1.0 addresses concepts and endpoints for studies of tobacco products and translates them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory applications.
This guide applies to products regulated by the FDA - CTP including synthetic nicotine and all products deemed to be a tobacco product, such as:
- Cigarettes
- Electronic Nicotine Delivery Systems nicotine delivery systems (ENDS; vapes) (Vapes)
- Roll-Your-Own Tobacco Productsyour-own tobacco products
- Smokeless Tobacco Productstobacco products
- Cigars
- Pipe Tobacco Productstobacco products
- Waterpipe Tobacco Productstobacco products
- Heated Tobacco Products tobacco products (HTPHTPs)
...
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| key | TOBA-151 |
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| key | TOBA-100 |
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Requirements for data submission to FDA
- CTP are defined and managed by FDA
- CTP and are out of scope for this guide. Tobacco products
listed above are
listed for example purposes only. Users of this guide
will should refer to FDA
- CTP guidance for products regulated by the agency
and for related submission requirements (available at https://www.fda.gov/tobacco-products).