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The Interventions domains in SDTM capture 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 Substance Use (SU )interventions 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, 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.
Several The examples are provided below to illustate 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. | ||||||||||||
| Example | ||||||||||||
| Include Page | CDASH Example.Recreational Products Used | CDASH Example.Recreational Products Used | ||||||||||
| Include Page | SDTM Example.Recreational Product Use | SDTM Example.Recreational Product Use | ||||||||||
| Example | ||||||||||||
| Include Page | CDASH Example.Tobacco Product Use History | CDASH Example.Tobacco Product Use History | ||||||||||
| Include Page | SDTM Example.Tobacco Product Use History | SDTM Example.Tobacco Product Use History | example||||||||||
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| Example | ||||||||||||
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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 | ||||||||||||
| Example | ||||||||||||
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.
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