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Several examples are provided below to illustrate the different ways recreational product usage may be collected in studies.
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This example collects data on all types of recreational products used by subjects. The sponsor only 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. Include Page |
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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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Example |
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This example illustrates how typical 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 stripsdips. 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. Include Page |
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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 Use History |
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| SDTM Example.Tobacco Use History |
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Example |
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This example illustates Include Page |
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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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Example |
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In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency. The sposnor only collected details on the last attempt to reduce nicotine dependency for each type of product used. CMTRT was selected from a pre-specified list. The sponsor did allow any other types of product to be listed. 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. pre-selected list. 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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