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Device events in In tobacco studies may consist of device problems (which may or may not result in adverse events), device-reported warnings or alarms, calibration events, and replacement of parts. This information is represented in the Device Events (DE) and associated domains. In device studies, cases where the device did not perform as expected are typically called "events" or "incidents," rather than "problems" or "malfunctions," because often , subjects may report events (problems) or malfunctions with the device used to deliver the tobacco product, 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.The applicant decides when tobacco product device events and malfunctions are collected. If malfunction or product event results in an adverse event, then that information should be recorded in the AE domain using the appropriate device-related variables (e.g., AEACNDEV, AERLDEV).

The Tobacco Product Events and Malfunctions (EM) domain is based on the Events general observation class and is used to represent device issues and/or events. 

There is more than one 1 approach to identifying devices in studiestobacco product devices involved with these events/incidents. The method chosen will depend upon the granularity at which the sponsor applicant 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 (e.g., a syringe), or its components can be separately identified (e.g., barrel, plunger, needle). The level of granularity a sponsor an applicant 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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