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Clinical Trials Studies involving a tobacco product may include assessments of pattern of product use, extent of exposure to toxicants and biological effecteffects, abuse potential, and consumer perception of the product, as well as other physiological and subjective effects. This may include nicotine pharmacokinetics, questionnaires, and daily diaries to assess tobacco and nicotine use status,   biomarkers of exposure as well as medical history, historyphysical examination, and physicals examinationsother routine data. These studies study types include abuse liability studies, in-laboratory clinical trials studies (subject uses the product once or a few times, but only in a laboratory setting), short-term clinical trials studies (<2 weeks of duration on a particular product), or intermediate-term clinical trials studies (> 2 weeks and ≤ 12 months), or long-term clinical trials studies (>12 months),. 

Most subject-level observations collected during the study should be represented according to one 1 of the 3 SDTM general observation classes, and the Specialspecial-purpose domains which  which represent data that does do not fit any of the general observation classes  See Domain Models Based on the General Observation Classes (Copy). and Models for Special-purpose Domains (Copy).classes. Given this, referring to both the CDASH Model when applicable and the SDTM is highly recommended when using domains to support understanding of intended scope and to inform extensions and creation of custom domains when needed. See also Section 2.1, How To Determine Where Data Belong, Section 2.7, Standards for Collection, and Section 2.8, Standards for Collection.

The examples in this section illustrate how to represent various aspects of studies involving a tobacco product using the CDASH Model and the SDTMThis section provides advice and examples for collecting and representing data in human clinical trials where the interest is evaluating tobacco product using the Clinical Data Acquisition Standards Harmonization (CDASH) model, and the Study Data Tabulation Model (SDTM), including

• guidance on the use of domains and variables;

• sample annotated case report forms ( aCRFs);

• examples of SDTM datasets, with text describing the situational context and pointing out example records of note. 

The domain specification table which tables include rows for all required and expected variables for a domain and for a set of permissible variables are described in detail in the Standards for Tabulation sectionmost likely relevant. The permissible variables do not include all the variables that are allowed for the domain; they are a set of variables that the SDS Team are considered likely to be included. The 

Users may also find other examples of how other particular kinds of data collection can be represented using CDISC standards in Therapeutic Area Data Standards User Guide that have been developed for various therapeutic area.