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The EM domain is an 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 that should be reported. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-193
Records are specific to an individual device. The entries may be related to one or many subjects, depending upon the type of device and scope of its use. Applicants will ensure that appropriate regulatory guidelines for reporting device events are followed. If a coding dictionary is used, non-standard variables 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-194
It is assumed that applicants will add collection fields to the following metadata specification as needed to meet scientific and regulatory requirements. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-195
If a malfunction or other 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).
Specification
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