You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 15 Next »

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), 

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 does 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).

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 the 

  • 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 records of note. 

The domain specification table include rows for all required and expected variables for a domain and for a set of permissible variables are 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.  

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.   

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. 


  • No labels