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Description/Overview
The EM domain is an events Events domain used to collect information on malfunctions and events that may occur in the use or testing of a tobacco product device.
These events may include malfunctions, calibrations, or parts replacement. It is an optional domain, to be used only if the applicant has events/issues with the tobacco product device that should be reported. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-193
Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
Records are specific to an individual tobacco product device. The entries may be related to one 1 or many subjects, depending upon the type of tobacco product device and scope of its use. Applicants will ensure that appropriate regulatory guidelines for reporting tobacco product device events are followed. If a coding dictionary is used, non-standard variables NSVs may need to be added to represent the various coding level variables defined in the dictionary. Event terms may be captured either as free text or via a prespecified list of terms. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-195
If a malfunction or other product event results in an a subject adverse eventexperience, then that information should be recorded in the AE domain using the appropriate device-related variables (e.g., AEACNDEV, AERLDEV).
Specification
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