Clinical Trials involving a tobacco product may include assessments of pattern of product use, extent of exposure to toxicants and biological effect, 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, and physicals examinations. 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), or intermediate-term clinical trials (> 2 weeks and ≤ 12 months), long-term clinical trials (>12 months),
Examples of the data collected in clinical trials involving a tobacco product are included in this section. Users may also find other examples of how other particular kinds of data collection can be represented using CDIS standards in Therapeutic Area Data Standards User Guide that have been developed for various therapeutic area.
It is important to note that the inclusion of concepts in this implementation guide should not be construed as a requirement to collect data on these concepts in any particular study. The examples included are intended to show how data of particular kinds can be represented using CDISC standards. The examples given are for guidance only and should not be over-interpreted.
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