Tobacco Product Issues and Events

In tobacco studies, subjects may report 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 "incidents," rather than "problems" or "malfunctions," because 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 Tobacco Product Issues and Events (PI) domain is based on the Events General Observation class and is used to represent device issues and/or events. 

There is more than one approach to identifying tobacco product devices involved with these events/incidents. 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.