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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 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 Tobacco Product Issues Events and Events Malfunctions (PIEM)) domain is based on the Events General Observation class and is used to represent device issues and/or events.
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This is an example of a study where the sponsor collected issues and events associated with the operation of the electronic cigarette product and any adverse events that a subject experienced as a result of the product issue or event.
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