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.
Several examples are provided below to illustate the different ways recreational product usage may be collected in studies.
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| CDASH Example.Recreational Products Used |
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| CDASH Example.Recreational Products Used |
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| SDTM Example.Recreational Product Use |
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| SDTM Example.Recreational Product Use |
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| CDASH Example.Tobacco Product Use History |
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| CDASH Example.Tobacco Product Use History |
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| SDTM Example.Tobacco Product Use History |
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| SDTM Example.Tobacco Product Use History |
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| CDASH Example.Products Used For Smoking Cessation |
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| CDASH Example.Products Used For Smoking Cessation |
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| SDTM Example.Products Used for Smoking Cessation |
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| SDTM Example.Products Used for Smoking Cessation |
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In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency. These products are represented in the Concomitant Medication (CM) domain. These products are not represented in the SU domaiin. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products. | Include Page |
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| CDASH Example.Products Used for Nicotine Dependency |
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| CDASH Example.Products Used for Nicotine Dependency |
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| SDTM Example.Products Used for Nicotine Dependency |
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| SDTM Example.Products Used for Nicotine Dependency |
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