Page History

...

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.  

The Interventions domains in SDTM capture The Interventions general-observation class domains are used to represent investigational, therapeutic, and other treatments that are products administered to the a subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g.protocol—for example, exposure to study product  product coincident with the study assessment period (e.g., concomitant medications), or —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 misused or abused or self-administered by the subject. These interventions are interventions that involve substances used for non-medical purposes and  which often maybe may be harmful to the individual or others. These include  (e.g., 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  represented in the Exposure (EX) and Exposure as Collected (EC) domains..

In clinical trials studying tobacco products, it has been decided that tobacco products being used for non-medical purpose purposes 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. 

The Substance Use (SU) domain is an interventions domain that contains substance use ((e.g., recreational product use).  Recreational drugs are chemical substances taken for enjoyment, or leisure purposes, rather than for medical reasons. 

...

.  

The examples provided here illustrate the different ways a subject's history of recreational product usage may be collected in studies.

Note:

• The Findings About Events or Interventions structure ("FA structure") is used to represent collected data that are findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. Not all findings associated with an event or intervention should be represented in the FA structure.
• The Findings About Events or Interventions (FA–) is a specialization of the Findings general observation class. It shares all qualities and conventions of findings observations but is specialized by the addition of the --OBJ variable. 

...