Page History

...

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 sponsor applicant has events that should be reported. 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. The structure of the EM domain is 1 record per device event per subject. Sponsors must 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.    

It is assumed that applicants will add collection fields to the following metadata specification as needed to meet scientific and regulatory requirements.

Specification

...