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In tobacco studies, subject may have problems with the tobacco product device used to deliver the tobacco product (E-cigarettes) (which may or may not result in adverse events), tobacco product warnings or alarms, calibration events, and replacement of parts. This information is represented in the Tobacco Product Issues and Events domain (PI). In studies, cases where the tobacco product device did not perform as expected are typically 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. 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.

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