TO BE REMOVED ; ISSUES TO BE DISCUSSED
1: Should we use SC for all details question about usage and quitting. or FASU.... (e.g. longest period of abstinence in the past year, Have you attempted to quit smoking, Number of previous attempts to quit smoking, Used patches) , Years of regular smokeless tobacco. (A type of tobacco that is not smoked or burned.) It may be used as chewing tobacco or moist snuff, or inhaled through the nose as dry snuff.)
2. 4, Is DOSFRM used to identify Chewing tobacco, snuff, etc. Is this then nicotine as the TRT and the route is ORAL SNUFF is inhalation.
INFORMATION ABOUT AGE Started smoking, AVERAGE CIGATEERS USED PER DAY, USED SMKELESS TOBACCO, E-Cigartees etc.
Types of tobacco use Cigarette,Cigars,Smokeless Tobacco,Pipe Tobacco,Nicotine Vaping Collected with Check all that appy in CDASH.
The Interventions domains in SDTM capture investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study product coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).
Recreational drugs are chemical substances taken for enjoyment, or leisure purposes, rather than for medical reasons. They are often drugs that are misused or abused or drugs self-administered by the subject. To support standardization, CDISC defined a Substance Use (SU) domain. This domain is used to represent intervention that are Substance Use (SU )interventions used for non-medical purposes and often maybe harmful to the individual or others. These include alcohol, marijuana and tobacco.
Other domains have been established to record other types of interventions. Interventions administered to the subject coincident with the study assessment period are referred to as concomitant medications and represented in the SDTM Concomitant/Prior Medications (CM) domain and interventions administered as protocol-specified study products are represented in the Exposure (EX) and Exposure as Collected (EC) domains..
In clinical trials studying tobacco products, tobacco products being used for non-medical purpose will be represented in the SU domain. However, products being used to reduce the usage of these self-administered tobacco products, will be considered either concomitant medications, or the product under study.
Example
This is the SDTM dataset used to represent the above collected data. The applicant populated SUPRESP="Y" for all substances specified in the drop-down list on the CRF. Other substances were not considered prespecified.
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