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Models Implemented in this Guide 

The TIG guid implement guides implementation of CDISC models to standardize collection , and representation, and exchange of tobacco product study data. The CDISC models implemented in this guide are:

• Version 1.2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at https://www.cdisc.org/standards/foundational/cdash/cdash-model-v1-2), which provides a general framework for creating fields to collect information on Case Report Forms (CRFs).
• Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, available at https://www.cdisc.org/standards/foundational/sdtm), which provides a standard model for study data tabulations.
• Version 2.1 of the CDISC Analysis Data Model (ADaM, available at https://www.cdisc.org/standards/foundational/adam) which specifies the principles and standards to follow in the creation of analysis datasets and associated metadata.

Additional Standards and Resources

The Additionally, the following standards and resources are referenced in this guide to further support implementation:

CDISC Controlled Terminology===

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