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The Interventions general-observation class domains are used to represent investigational, therapeutic, and other products administered to a subject (with some actual or expected physiological effect) either as specified by the study protocol—for example, 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, caffeine).
Recreational drugs are chemical substances taken for enjoyment , or leisure purposes, rather than for medical reasons.
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Alcohol; Tobacco; Marijuana. Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; OTher
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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 interventions that involve substances used for non-medical purposes and which often may be harmful to the individual or others (e.g., alcohol, marijuana, 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 Concomitant/Prior Medications (CM) domain; interventions administered as protocol-specified study products are represented in the Exposure (EX) and Exposure as Collected (EC) domains.
In trials studying tobacco products, tobacco products being used for non-medical purposes will be represented in the SU domain. However, products used to reduce the usage of these self-administered tobacco products will be considered either concomitant medications or the product under study.
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.
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This example CRF collects data on all types of recreational products previously used by the subject. The applicant only collected the general type of product used; the actual dates of usage were not collected. The subject provided the duration of use. Usage of these recreational products is represented in the SU domain.
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This example CRF illustrates how tobacco use history data could be collected—including cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco dips; this example does not include tobacco products used as a medically acceptable therapy for smoking cessation. The specific brand name of the product was collected. The applicant collected whether the product was still being used, and if not, the end date of usage. Usage of these products is represented in the SU domain.
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Pagenav
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