Tobacco Product Device Events

In tobacco studies, subject may have problems with the tobacco product device used to deliver the tobacco product (E-cigarettes) (which may or may not result in adverse events), tobacco product warnings or alarms, calibration events, and replacement of parts. This information is represented in the Tobacco Product Issues and Events domain (PI). In studies, cases where the tobacco product device did not perform as expected are typically called "events" or "incidents," rather than "problems" or "malfunctions," because often the true cause of the issue cannot be determined until a cause analysis is performed. This may or may not be a concern for a given trial depending upon whether the device has already been approved by regulators. Typically, post-approval device studies are less concerned about root-issue attribution.

There is more than one approach to identifying tobacco product devices in studies. The method chosen will depend upon the granularity at which the sponsor 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 a sponsor 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.