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This 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, 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 records of note; and

The primary focus will be illustrating concept specifically related to clinical trials using tobacco products.  Advice and examples for topics that are essentially the same as for Human Clinical trials, can be found in ...     

All studies All studies,

FYI:  Examples of what is collected 

Study protocol for a non-inferiority trial of cytisine versus nicotine replacement therapy in people motivated to stop smoking

•  Age when started, number of cigarettes smoked per day, number of years as regular smoker, number of previous unsuccessful attempts to give up in past 12 months and the method used, type of cigarettes smoked per day (e.g. roll-your-own or factory-made) and usual brand/pack size (and how long pack lasts for roll-your-own users).

• Other smoking related information: Self-rated chances of quitting, household smoking, and smoking in cars. Satisfaction with smoking will also be assessed at baseline (and at follow-up), using the modified Cigarette Evaluation Questionnaire (mCEQ) [25]. This questionnaire was used in the one trial (n = 746) that has compared the effect of varenicline versus NRT on quit rates [26]. This trial found varenicline use resulted in significantly less satisfaction with smoking compared to NRT use, in those participants that did not quit smoking. It is important to determine if cytisine, given it is a similar class of drug to varenicline, has an analogous effect.

• Concomitant medication: Information about types of medication currently used will be collected.

• The physical signs and symptoms associated with withdrawal: Measured using the Mood and Physical Symptoms Scale (MPSS) [27].

• Alcohol use and abuse: Data from both animal [28] and human studies [29] have shown that varenicline can also reduce alcohol consumption. Given cytisine is a similar class of drug as varenicline it may have an analogous effect on alcohol use, although to date no such effect has been published. For this reason, information about alcohol use and abuse will be collected in this study, using the Alcohol Use Disorders Identification Test-consumption subscale [AUDIT-C], a screening tool that helps to identify people who are hazardous drinkers or have an active alcohol use disorder (including alcohol abuse or dependence) [30].

Breath carbon monoxide (CO) was measured using a Bedfont Micro+ Smokerlyzer (Haddonfield, NJ). Urine samples were collected and sent to an independent laboratory (Friends Medical Laboratory, Baltimore, MD) for analysis of cotinine, a metabolite of nicotine.

Target-Quit Date (TQD),  guidelines recommend that smokers should set a target quit date (TQD) at treatment onset because making a public commitment to quit on.. ,, Model this at baseline as Trial MIlestone.  

measuring exhaled carbon monoxide (CO)
concentrations with a value of < 5 ppm confirming abstinence.

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Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings.