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The Interventions general observational class of domains is used to represent 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 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 illustrate the different ways the subjects's history of recreational product usage may be collected in studies. Note, that the Findings About Events or Interventions structure (or "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 collects data on all types of recreational products previosuly used by the subject. The sponsor only collected the general type of product used. The actual dates of usage were also not collected. The subject provided the duration of use. Usage of these recreational products are represented in the SU domain.
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This example illustrates how tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapy for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco dips. The specific brand name of the product was collected. The sponsor collected whether the product was still being used, and if not the end date of usage. Usage of these products are represented in the SU domain.
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In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sposnor only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.
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This example is an additional example of data collected on the previous use of smoking cessation products at the baseline visit. This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.
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