Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Example

This example illustrates how tobacco use history data could be collected. This example does not include  tobacco products that are  being used as a medically acceptable therapy for smoke smoking 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 is represented in the SU domain.  

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

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sposnor sponsor 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.

Include Page
CDASH Example.Medications Used for Nicotine Dependency
CDASH Example.Medications Used for Nicotine Dependency

Include Page
SDTM Example.Products Used for Nicotine Dependency
SDTM Example.Products Used for Nicotine Dependency

...