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recaps the basic concepts of the SDTM, and describes how this implementation guide should be used in concert with the SDTM.

The

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TIG provides guidance for how to use CDISC standards for

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the collection and representation of tobacco product study data.

Provided in this guide are advice and examples for the Clinical Data Acquisition Standards Harmonization (CDASH) model, the Study Data Tabulation Model (SDTM), and the Analysis Data Model (ADaM), including

• guidance on the use of domains and variables; and
• sample annotated case report forms (aCRFs);
• examples of SEND and SDTM datasets, with text describing the situational context and pointing out records of note; and
• guidance on the use of ADaM and other analysis datasets

Data collection and Data Tabulation standards have been developed in this guide and are described in Section X ????.  These standards are based on the SDTM Model. The SDTM model has been designed to represent the broadest range of human and animal study data in a standardized manner.  This SDTM Model document  ( REF ) describes the basic concepts and general structure of the model. Individual implementation guides (IGs) have also been created to provide detail specification and recommendations for representing  data commonly collected. The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) https://www.cdisc.org/standards/foundational/sdtmig provides useful guidelines for creating data tabulations for Human Clinical Trials. Since, data tabulations and clinical study reports on tobacco products are operationally similar to data tabulations and clinical study reports prepared for Human Clinical Trials, the SDTMIG was employed in developing this section.  

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