Page History

In tobacco studies, subjects may report events (problems) or malfunctions with the device used to deliver the tobacco product, which may or may not result in adverse events. These may be called "events" or "malfunctions." Often the true cause of the issue cannot be determined until a cause analysis is performed. Theses device related issues or events may or may not be a concern for a given trial depending upon whether the device has already been approved by regulators. The applicant decides when tobacco product device events and malfunctions are collected.  . If malfunction or product event results in an adverse event, then that information should be recorded in the AE domain using the appropriate device-related variables (e.g., AEACNDEV, AERLDEV).

The Tobacco Product Events and Malfunctions (EM)) domain is based on the Events General Observation general observation class and is used to represent device issues and/or events. 

There is more than one 1 approach to identifying tobacco product devices involved with these events/incidents. The method chosen will depend upon the granularity at which the applicant needs to track the tobacco product devices and will affect how the data are modeled. A tobacco product device can be identified as a single unit or its components can be separately identified. The level of granularity an applicant chooses will be influenced by whether the components will be replaced and/or tracked, and how tobacco product device/adverse event relationships and actions taken will be assessed.

...