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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 misused or abused or self-administered by the subject. These interventions 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, it has been decided that 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 studyThe 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


Example

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Recreational Drug Product Use Example
Recreational Drug Product Use Example

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