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There is more than one approach to identifying tobacco product devices in studiesinvolved 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.
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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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