Page History
...
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.
Example | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
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.
|