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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.

Events represented in the EM domain will be consistent with scientific and regulatory requirements. It is the applicant's responsibility to define an event and the appropriate collection period for events. This definition may vary based on product characterization and reporting of product safety. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection. 

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.    

It is assumed that applicants will add collection fields to the following metadata specification as needed to meet scientific and regulatory requirementsIf a malfunction or other product event results in a subject adverse experience, then that information should be recorded in the AE domain.

Specification

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