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This guide describes how to implement CDISC models to standardize collection, 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.

This guide also references the following CDISC standards to support data exchange:

• Version 2.0 of the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), which provides a vendor-neutral, platform-independent format for representing and exchanging CRF content in electronic data capture (EDC) tools.
• Version 2.1 of the CDISC Define-XML (Define-XML, available at https://www.cdisc.org/standards/data-exchange/define-xml/define-xml-v2-1), which provides a metadata standard used to describe any tabular dataset structure.