Product Impact on Individual Health

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

Most subject-level observations collected during the study should be represented according to one of the 3 SDTM general observation classes, and the Special-purpose domains which represent data that do not fit any of the general observation classes. See Domain Models Based on the General Observation Classes TOBA-281 - Getting issue details... STATUS and Models for Special-purpose Domains.

The examples in this section illustrate how to represent various aspects of clinical trials involving a 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 context and example records of note. 

The domain specification tables  include rows for all required and expected variables for a domain and for a set of permissible variables are most likely relevant. The permissible variables do not include all the variables that are allowed for the domain; they are a set of variables that are considered likely to be included.